更新于：2024-12-13
Teriflunomide
特立氟胺
更新于：2024-12-13
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2012-09-12), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (韩国) |
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结构
分子式C12H9F3N2O2 |
InChIKeyUTNUDOFZCWSZMS-YFHOEESVSA-N |
CAS号163451-81-8 |
关联
60
项与 特立氟胺 相关的临床试验The Combination of Teriflunomide and High-dose Dexamethasone vs High-dose Dexamethasone Alone as First-line Treatment for Newly Diagnosed Adult Primary Immune Thrombocytopenia (ITP): A Prospective, Multicenter, Randomized Trial
A randomized, open-label, multicenter study to compare the efficacy and safety of teriflunomide plus high-dose dexamethasone compared to high-dose dexamethasone monotherapy for the first-line treatment of adults with newly diagnosed primary immune thrombocytopenia (ITP).
开始日期2023-12-19 |
申办/合作机构 北京大学人民医院 [+9] |
A Multicenter, Open-label, Randomized, Controlled, Phase 2 Trial Comparing the Efficacy and Safety of Teriflunomide Plus Danazol in Patients With Steroid-resistant/Relapse ITP
To compare the efficacy and safety of teriflunomide plus danazol versus danazol in patients with steroid-resistant/relapse ITP
开始日期2023-12-05 |
申办/合作机构 北京大学人民医院 [+9] |
A Single-arm, Open-label Phase II Study to Determine the Safety and Efficacy of Teriflunomide in Patients With Steroid-resistant/Relapse Thrombocytopenia
Single-arm, open-label, single-center study to evaluate the efficacy and safety of teriflunomide for the treatment of adults with steroid-resistant/relapse immune thrombocytopenia (ITP).
开始日期2023-12-05 |
申办/合作机构 |
100 项与 特立氟胺 相关的临床结果
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100 项与 特立氟胺 相关的转化医学
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100 项与 特立氟胺 相关的专利（医药）
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1,024
项与 特立氟胺 相关的文献（医药）2025-01-01·Caspian Journal of Internal Medicine
De-escalation of anti-CD20 monoclonal antibodies to low-moderate efficacy disease-modifying treatments (DMTs) in patients with relapse-remitting multiple sclerosis: An initial Iranian experience.
Article
作者: Naser Moghadasi, Abdorreza ; Paybast, Sepideh ; Rezaeimanesh, Nasim
Background:
Anti-CD20 are among the high-efficacy DMTs commonly used in treating multiple sclerosis (MS). Long-term safety data on anti-CD20s are limited. There is convincing evidence of hypogammaglobulinemia in the long-term use of anti-CD20s, raising the likelihood of infection. Accordingly, there is an unmet need for de-escalation therapy in stable patients to reduce adverse events. Herein we aimed to describe our experience with ten relapse-remitting MS (RRMS) patients who were switched from anti-CD20s to the low-moderate efficacy DMTs.
Methods:
This cohort study was conducted between January 2020 and February 2023 at the MS Research Center of Sina Hospital, Tehran, Iran, to identify the characteristics of RRMS patients who were switched from anti-CD20s to low-moderate efficacy DMTs within 12 months of the last anti-CD20 infusion. Patients were then followed up to 18 months after de-escalation.
Results:
All patients were females, with a mean age of 39.3±2.53-year-old and a mean disease duration of 9.7±1.39 years. After a mean of 2.95±0.44 years of treatment with anti-CD20s, patients were de-escalated to INF-β1a (n=5), dimethyl fumarate (DMF) (n=3), fingolimod (n=1), and teriflunomide (n=1). The main reason for anti-CD20 discontinuation was an infectious concern. Within 18 months of follow-up, no patient developed clinical or MRI activity. Additionally, we did not find evidence of disability progression in any patients (P=0.13).
Conclusion:
The present study is a real-world experience of de-escalating anti-CD20s to low-moderate efficacy DMTs, which suggests that at short-term follow-up, de-escalating anti-CD20s appeared to be effective and safe in RRMS patients.
2025-01-01·CLINICAL NEUROLOGY AND NEUROSURGERY
Restless legs syndrome associated with teriflunomide use in two patients with multiple sclerosis
Article
作者: Aksoy, Dürdane ; Çevik, Betül
Teriflunomide is an oral agent that has long been used to treat relapsing-remitting multiple sclerosis. Teriflunomide inhibits the rapid proliferation of T and B lymphocytes by inhibiting the activity of dihydroorotate dehydrogenase. Common side effects include headache, alanine aminotransferase level elevation, hair thinning, and arthralgia. Cases of restless legs syndrome (RLS) associated with the use of teriflunomide have not been previously reported; however, RLS is more frequently observed in patients with multiple sclerosis (MS) than in healthy individuals. Herein, we present two patients with MS with low Expanded Disability Status Scale scores who developed RLS symptoms shortly after starting teriflunomide and whose complaints improved immediately after discontinuing the drug. These cases emphasize the need to consider RLS as a potential side effect of teriflunomide treatment in patients with MS, in whom RLS is more common.
2024-12-31·Journal of medical economics
Comparative effectiveness and cost-effectiveness of natalizumab and fingolimod in rapidly evolving severe relapsing-remitting multiple sclerosis in the United Kingdom
Article
作者: Garber, J. ; Eichau, S. ; Hyde, R. ; Kalincik, T. ; Castillo-Triviño ; Buzzard, K. ; Petersen, T. ; Jose Sa, M. ; Ferraro, D. ; Butzkueven, H. ; van Pesch, V. ; Hodgkinson, S. ; Jokubaitis, V. G. ; Hughes, S. ; Iuliano, G. ; Fragoso, Y. ; Lugaresi, A. ; Laureys, G. ; Spelman, T. ; de Gans, K. ; De Luca, G. ; van der Walt, A. ; Trojano, M. ; Izquierdo, G. ; Oreja-Guevara ; Sas, A. ; Gouider, R. ; Ozakbas, S. ; Solaro, C. ; Horakova, D. ; Ampapa, R. ; Bergamaschi, R. ; Aguera Morales, E. ; Slee, M. ; Soysal, A. ; Acosta, C. ; Duquette, P. ; Van Wijmeersch, B. ; Patti, F. ; Shaygannejad, V. ; Sanchez-Menoyo, J. L. ; Gray, O. ; Ramo-Tello, C. ; John, N. ; Skibina, O. ; Spitaleri, D. ; Granella, F. ; Alroughani, R. ; Cartechini, E. ; Herring, W. L. ; Gerlach, O. ; Moore, F. ; Prevost, J. ; Havrdova, E. K. ; Girard, M. ; Simo, M. ; Rajda, C. ; Grand’Maison, F. ; Csepany, T. ; Onofrj, M. ; Pucci, E. ; McCombe, P. ; Terzi, M. ; Karabudak, R. ; Rozsa, C.
AIM:
To evaluate the real-world comparative effectiveness and the cost-effectiveness, from a UK National Health Service perspective, of natalizumab versus fingolimod in patients with rapidly evolving severe relapsing-remitting multiple sclerosis (RES-RRMS).
METHODS:
Real-world data from the MSBase Registry were obtained for patients with RES-RRMS who were previously either naive to disease-modifying therapies or had been treated with interferon-based therapies, glatiramer acetate, dimethyl fumarate, or teriflunomide (collectively known as BRACETD). Matched cohorts were selected by 3-way multinomial propensity score matching, and the annualized relapse rate (ARR) and 6-month-confirmed disability worsening (CDW6M) and improvement (CDI6M) were compared between treatment groups. Comparative effectiveness results were used in a cost-effectiveness model comparing natalizumab and fingolimod, using an established Markov structure over a lifetime horizon with health states based on the Expanded Disability Status Scale. Additional model data sources included the UK MS Survey 2015, published literature, and publicly available sources.
RESULTS:
In the comparative effectiveness analysis, we found a significantly lower ARR for patients starting natalizumab compared with fingolimod (rate ratio [RR] = 0.65; 95% confidence interval [CI], 0.57-0.73) or BRACETD (RR = 0.46; 95% CI, 0.42-0.53). Similarly, CDI6M was higher for patients starting natalizumab compared with fingolimod (hazard ratio [HR] = 1.25; 95% CI, 1.01-1.55) and BRACETD (HR = 1.46; 95% CI, 1.16-1.85). In patients starting fingolimod, we found a lower ARR (RR = 0.72; 95% CI, 0.65-0.80) compared with starting BRACETD, but no difference in CDI6M (HR = 1.17; 95% CI, 0.91-1.50). Differences in CDW6M were not found between the treatment groups. In the base-case cost-effectiveness analysis, natalizumab dominated fingolimod (0.302 higher quality-adjusted life-years [QALYs] and £17,141 lower predicted lifetime costs). Similar cost-effectiveness results were observed across sensitivity analyses.
CONCLUSIONS:
This MSBase Registry analysis suggests that natalizumab improves clinical outcomes when compared with fingolimod, which translates to higher QALYs and lower costs in UK patients with RES-RRMS.
240
项与 特立氟胺 相关的新闻（医药）2024-11-21
NEW YORK, Nov. 21, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced it ranked number one on the Deloitte Technology Fast 500™, a ranking of the 500 fastest-growing technology, media, telecommunications, life sciences, fintech, and energy tech companies in North America, now in its 30th year.
The Company’s growth between fiscal years 2020 to 2023 was fueled by BRIUMVI® revenues, which was approved to treat adult individuals with relapsing forms of multiple sclerosis in December of 2022.
Michael S. Weiss, the Company’s Chairman and Chief Executive Officer stated, “We are proud to be recognized as the fastest-growing company in North America on the Deloitte Technology Fast 500 list. This recognition reflects the unwavering commitment of our incredible team and the strong success in bringing BRIUMVI to people with relapsing forms of multiple sclerosis. As we continue our mission to develop and provide treatment alternatives for those in need, we are grateful for the trust and support we have received from the multiple sclerosis community.”
About the 2024 Deloitte Technology Fast 500Now in its 30th year, the Deloitte Technology Fast 500 provides a ranking of the fastest-growing technology, media, telecommunications, life sciences, fintech, and energy tech companies — both public and private — in North America. Technology Fast 500 award winners are selected based on percentage fiscal year revenue growth from 2020 to 2023.
In order to be eligible for Technology Fast 500 recognition, companies must own proprietary intellectual property or technology that is sold to customers in products that contribute to a majority of the company’s operating revenues. Companies must have base-year operating revenues of at least US$50,000, and current-year operating revenues of at least US$5 million. Additionally, companies must be in business for a minimum of four years and be headquartered within North America.
About DeloitteDeloitte provides industry-leading audit, consulting, tax and advisory services to many of the world’s most admired brands, including nearly 90% of the Fortune 500® and more than 8,500 U.S.-based private companies. At Deloitte, we strive to live our purpose of making an impact that matters by creating trust and confidence in a more equitable society. We leverage our unique blend of business acumen, command of technology, and strategic technology alliances to advise our clients across industries as they build their future. Deloitte is proud to be part of the largest global professional services network serving our clients in the markets that are most important to them. Bringing more than 175 years of service, our network of member firms spans more than 150 countries and territories. Learn how Deloitte’s approximately 460,000 people worldwide connect for impact at www.deloitte.com.
ABOUT TG THERAPEUTICSTG Therapeutics is a fully integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG has received U.S. Food and Drug Administration (FDA) approval for BRIUMVI® (ublituximab-xiiy), for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features in Europe and the United Kingdom, respectively. For more information, visit www.tgtherapeutics.com, and follow us on X (formerly Twitter) @TGTherapeutics and on LinkedIn.
BRIUMVI® is a registered trademark of TG Therapeutics, Inc.
ABOUT BRIUMVI® (ublituximab-xiiy) 150 mg/6 mL Injection for IVBRIUMVI is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of autoimmune disorders, such as RMS. BRIUMVI is uniquely designed to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion at low doses.
BRIUMVI is indicated for the treatment of adults with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
A list of authorized specialty distributors can be found at www.briumvi.com. IMPORTANT SAFETY INFORMATION
Contraindications: BRIUMVI is contraindicated in patients with:
Active Hepatitis B Virus infectionA history of life-threatening infusion reaction to BRIUMVI
WARNINGS AND PRECAUTIONS
Infusion Reactions: BRIUMVI can cause infusion reactions, which can include pyrexia, chills, headache, influenza-like illness, tachycardia, nausea, throat irritation, erythema, and an anaphylactic reaction. In MS clinical trials, the incidence of infusion reactions in BRIUMVI-treated patients who received infusion reaction-limiting premedication prior to each infusion was 48%, with the highest incidence within 24 hours of the first infusion. 0.6% of BRIUMVI-treated patients experienced infusion reactions that were serious, some requiring hospitalization.
Observe treated patients for infusion reactions during the infusion and for at least one hour after the completion of the first two infusions unless infusion reaction and/or hypersensitivity has been observed in association with the current or any prior infusion. Inform patients that infusion reactions can occur up to 24 hours after the infusion. Administer the recommended pre-medication to reduce the frequency and severity of infusion reactions. If life-threatening, stop the infusion immediately, permanently discontinue BRIUMVI, and administer appropriate supportive treatment. Less severe infusion reactions may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment.
Infections: Serious, life-threatening or fatal, bacterial and viral infections have been reported in BRIUMVI-treated patients. In MS clinical trials, the overall rate of infections in BRIUMVI-treated patients was 56% compared to 54% in teriflunomide-treated patients. The rate of serious infections was 5% compared to 3% respectively. There were 3 infection-related deaths in BRIUMVI-treated patients. The most common infections in BRIUMVI-treated patients included upper respiratory tract infection (45%) and urinary tract infection (10%). Delay BRIUMVI administration in patients with an active infection until the infection is resolved.
Consider the potential for increased immunosuppressive effects when initiating BRIUMVI after immunosuppressive therapy or initiating an immunosuppressive therapy after BRIUMVI.
Hepatitis B Virus (HBV) Reactivation: HBV reactivation occurred in an MS patient treated with BRIUMVI in clinical trials. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with anti-CD20 antibodies. Perform HBV screening in all patients before initiation of treatment with BRIUMVI. Do not start treatment with BRIUMVI in patients with active HBV confirmed by positive results for HBsAg and anti-HB tests. For patients who are negative for surface premedantigen [HBsAg] and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult a liver disease expert before starting and during treatment.
Progressive Multifocal Leukoencephalopathy (PML): Although no cases of PML have occurred in BRIUMVI-treated MS patients, JCV infection resulting in PML has been observed in patients treated with other anti-CD20 antibodies and other MS therapies.
If PML is suspected, withhold BRIUMVI and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.
MRI findings may be apparent before clinical signs or symptoms; monitoring for signs consistent with PML may be useful. Further investigate suspicious findings to allow for an early diagnosis of PML, if present. Following discontinuation of another MS medication associated with PML, lower PML-related mortality and morbidity have been reported in patients who were initially asymptomatic at diagnosis compared to patients who had characteristic clinical signs and symptoms at diagnosis.
If PML is confirmed, treatment with BRIUMVI should be discontinued.
Vaccinations: Administer all immunizations according to immunization guidelines: for live or live-attenuated vaccines at least 4 weeks and, whenever possible at least 2 weeks prior to initiation of BRIUMVI for non-live vaccines. BRIUMVI may interfere with the effectiveness of non-live vaccines. The safety of immunization with live or live-attenuated vaccines during or following administration of BRIUMVI has not been studied. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion.
Vaccination of Infants Born to Mothers Treated with BRIUMVI During Pregnancy: In infants of mothers exposed to BRIUMVI during pregnancy, assess B-cell counts prior to administration of live or live-attenuated vaccines as measured by CD19+ B-cells. Depletion of B-cells in these infants may increase the risks from live or live-attenuated vaccines. Inactivated or non-live vaccines may be administered prior to B-cell recovery. Assessment of vaccine immune responses, including consultation with a qualified specialist, should be considered to determine whether a protective immune response was mounted.
Fetal Risk: Based on data from animal studies, BRIUMVI may cause fetal harm when administered to a pregnant woman. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 B-cell depleting antibodies during pregnancy. A pregnancy test is recommended in females of reproductive potential prior to each infusion. Advise females of reproductive potential to use effective contraception during BRIUMVI treatment and for 6 months after the last dose.
Reduction in Immunoglobulins: As expected with any B-cell depleting therapy, decreased immunoglobulin levels were observed. Decrease in immunoglobulin M (IgM) was reported in 0.6% of BRIUMVI-treated patients compared to none of the patients treated with teriflunomide in RMS clinical trials. Monitor the levels of quantitative serum immunoglobulins during treatment, especially in patients with opportunistic or recurrent infections, and after discontinuation of therapy until B-cell repletion. Consider discontinuing BRIUMVI therapy if a patient with low immunoglobulins develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins.
Most Common Adverse Reactions: The most common adverse reactions in RMS trials (incidence of at least 10%) were infusion reactions and upper respiratory tract infections.
Physicians, pharmacists, or other healthcare professionals with questions about BRIUMVI should visit www.briumvi.com.
ABOUT BRIUMVI PATIENT SUPPORT BRIUMVI Patient Support is a flexible program designed by TG Therapeutics to support U.S. patients through their treatment journey in a way that works best for them. More information about the BRIUMVI Patient Support program can be accessed at www.briumvipatientsupport.com.
ABOUT MULTIPLE SCLEROSIS Relapsing multiple sclerosis (RMS) is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing-remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses. RRMS is the most common form of multiple sclerosis (MS) and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. It is estimated that nearly 1 million people are living with MS in the United States and approximately 85% are initially diagnosed with RRMS.1,2 The majority of people who are diagnosed with RRMS will eventually transition to SPMS, in which they experience steadily worsening disability over time. Worldwide, more than 2.3 million people have a diagnosis of MS.1
ABOUT TG THERAPEUTICSTG Therapeutics is a fully integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG has received U.S. Food and Drug Administration (FDA) approval for BRIUMVI® (ublituximab-xiiy), for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features in Europe and the United Kingdom, respectively. For more information, visit www.tgtherapeutics.com, and follow us on X (formerly Twitter) @TGTherapeutics and on LinkedIn.
BRIUMVI® is a registered trademark of TG Therapeutics, Inc.
Cautionary StatementThis press release contains forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release. In addition to the risk factors identified from time to time in our reports filed with the U.S. Securities and Exchange Commission (SEC), factors that could cause our actual results to differ materially include the below.
Such forward looking statements include but are not limited to statements regarding expectations for the commercial launch of BRIUMVI® (ublituximab-xiiy) for RMS in the United States; and anticipated healthcare professional (HCP) and patient acceptance and use of BRIUMVI for the approved indications.
Additional factors that could cause our actual results to differ materially include the following: the Company’s ability to continue to maintain a commercial infrastructure for BRIUMVI, and to successfully market and sell BRIUMVI; the risk that the Company’s BRIUMVI U.S. net revenue targets will not be achieved; the failure to obtain and maintain requisite regulatory approvals, including the risk that the Company fails to satisfy post-approval regulatory requirements, the potential for variation from the Company’s projections and estimates about the potential market for BRIUMVI due to a number of factors, including, further limitations that regulators may impose on the required labeling for BRIUMVI (such as modifications, resulting from safety signals that arise in the post-marketing setting or in the long-term extension study from the ULTIMATE I and II clinical trials); the Company’s ability to meet post-approval compliance obligations (on topics including but not limited to product quality, product distribution and supply chain, pharmacovigilance, and sales and marketing); the Company’s reliance on third parties for manufacturing, distribution and supply, and other support functions for its clinical and commercial products, including BRIUMVI, and the ability of the Company and its manufacturers and suppliers to produce and deliver BRIUMVI to meet the market demand for BRIUMVI; and general political, economic and business conditions. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 and in our other filings with the SEC.
Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only. CONTACT:
Investor Relations: Email: ir@tgtxinc.comTelephone: 1.877.575.TGTX (8489), Option 4Media Relations: Email: media@tgtxinc.com Telephone: 1.877.575.TGTX (8489), Option 6
1. MS Prevalence. National Multiple Sclerosis Society website. https://www.nationalmssociety.org/About-the-Society/MS-Prevalence. Accessed October 26, 2020. 2. Multiple Sclerosis International Federation, 2013 via Datamonitor p. 236.
上市批准临床结果疫苗
2024-11-08
·药智网
近年来，神经学药物市场持续充满活力，新的治疗方法迎合了广泛的神经和精神疾病治疗需求。
2023年神经学领域畅销药TOP20榜单显示，神经学药物最高销售额达71亿美元，有7个品种年销售额均超20亿美元。
>01<
神经学领域畅销药TOP20
从榜单来看（下表1），TOP20药物中有18个品种在2023年全球销售额达到10亿美元，其中2个年销售额超过50亿美元。
表1 2023年神经学畅销药TOP20
数据来源：xtalks
注：由于货币汇率波动，销售额换算统一货币时略有差异。
罗氏的奥瑞利珠单抗在2023年销售额达到71.03亿美元，夺得神经学领域药物“药王”宝座，今年上半年奥瑞利珠单抗药销售额继续实现一位数增长，达到33.59亿美元，同比增长5%。目前，排名前七的药物半年销售额均超过20亿美元，且其中5个品种实现两位数的同比增长率，未来仍有不少增长空间。
值得一提的是，辉瑞旗下的偏头痛药物瑞美吉泮在2023年销售额同比大增335.6%，达到9.28亿美元，这一数据反映了该药物在市场上的强劲表现和需求增长。
从药物类别来看（下图2），小分子药物（75%）是主要的药物类型，其次为单抗（15%），基因疗法药物和其他蛋白药物占比10%。
图1 2023年神经学畅销药分类
数据来源：公开资料整理
从适应症来看（下图3），这20款药物适应症主要集中在多发性硬化症（6款）和精神分裂症（5款）上面，分别占比30%和25%，由此可见这两种药物具有广泛的市场需求。
图2 2023年神经学畅销药适应症分布
数据来源：公开资料整理
>02<
罗氏持续领跑
2023年神经学领域药物全球销售总额排名前三的企业分别是罗氏（87.49亿美元）、艾伯维（84.32亿美元）和诺华（51.96亿美元）。
罗氏凭借2款产品（奥瑞利珠单抗和利司扑兰）在神经学药物领域持续领跑，其中Ocrevus（奥瑞利珠单抗）是一种cd20导向的细胞溶解抗体，用于治疗复发型多发性硬化症，包括临床孤立综合征、复发缓解型疾病和活动性继发进行性疾病，以及成人原发性进行性多发性硬化症。
这是首个也是唯一被批准用于治疗重度致残性多发性硬化症的疾病改善疗法，也被批准用于治疗复发性多发性硬化症（RMS）。在RMS中，Ocrevus被证明优于Rebif（干扰素β-1a），一种常用的RMS疗法，在一项临床研究中，Ocrevus是第一个也是唯一一个在中位治疗时间为三年的PPMS中显著减缓进展的治疗方法。
根据罗氏2023年年度报告，Ocrevus的销售额约为71亿美元，增长12.3%，其中包括美国新患者和保留患者的11%增长。另一款产品用于治疗小儿和成人脊髓性肌萎缩症（SMA）的Evrysdi（利司扑兰)。Evrysdi是第一种口服药物，也是第二种被批准用于治疗SMA的药物。Evrysdi2023年全球销售额为16.46亿美元，增长34.6%。
罗氏堪称TOP药企里的“造星之王”。当前，罗氏在神经领域的研发侧重于神经肌肉疾病、神经免疫性疾病、神经退行性疾病与神经发育性疾病等亚专科领域，涵盖帕金森病、阿尔茨海默病、多发性硬化、视神经脊髓炎谱系疾病、重症肌无力、脊髓性肌萎缩症等疾病，如Trontinemab、奥瑞利珠单抗、萨特利珠单抗、利司扑兰都是不同疾病领域内的代表性药物。在其现有的87个新化合物和65个附加适应症临床管线当中，神经学管线布局（20项）规模仅次于肿瘤（43项），且远超其他领域。
>03<
多款MS药物发力
多发性硬化（MS）是一种免疫介导的中枢神经系统炎性脱髓鞘疾病，其病变具有时间多发与空间多发的特征。在过去的10年中，MS在流行病学、病理学、疾病活动与进展等领域的相关研究推动了该病临床分型、诊断标准、治疗目标的更新，新的疾病修正治疗药物也为治疗策略提供了更多选择。
从榜单来看，TOP20药物中有6款产品用于治疗多发性硬化症，分别是Ocrevus(奥瑞利珠单抗)、Kesimpta（奥法妥木单抗）、Tysabri（那他珠单抗）、Gilenya（芬戈莫德）、Aubagio（特立氟胺）和Tecfidera（富马酸二甲酯）。
其中，来自诺华的Kesimpta 2023年全球销售额达21.71亿美元，同比增长99%，成为诺华增长主力。Kesimpta因其强大的疗效和良好的安全性而脱颖而出，并提供了在家自我给药的便利。截至2024年10月22日，该药物是全球唯一一款可通过每月一次居家自行管理的B细胞靶向疗法。
该药物MS适应症在美国获批上市次年（2021年），同适应症即在中国获批上市，作为“优先审批类别”，诺华以最快的速度，实现产品在中国与欧美国家的同步上市。2024年10月30日，诺华发布2024年第三季度财报，Kesimpta这款用于治疗多发性硬化症的药物继续表现优异，2024年第三季度销售额飙升至8.38亿美元，同比增长28%，推动诺华在免疫领域的收入。
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结语
众多药企对神经学药物市场的重视将导致竞争愈发激烈。一方面，大型药企凭借其丰富的资源和研发经验，将继续巩固在市场中的地位，如罗氏、艾伯维等公司可能会进一步拓展其神经学药物产品线和适应症范围。另一方面，小型药企和生物科技公司可能会通过聚焦细分领域或开发创新性药物来寻求突破，市场可能会逐渐分化为头部企业占据主要市场份额，而特色鲜明的小型企业在特定领域或小众适应症中崭露头角。神经学药物市场未来发展如何？我们拭目以待。
参考资料
1.https://xtalks.com/top-20-best-selling-neurology-drugs-to-watch-in-2024-3931/
2.药智数据
3.各种企业官微、官网及公开资料
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基因疗法细胞疗法
2024-10-29
Ad hoc announcement pursuant to Art. 53 LR Q3 net sales grew +10% (cc1, +9% USD) with core operating income up +20% (cc, +17% USD) Sales growth driven by continued strong performance from Entresto (+26% cc), Cosentyx (+28% cc), Kisqali (+43% cc), Kesimpta (+28% cc), Pluvicto (+50% cc) and Leqvio (+119% cc)Core operating income margin 40.1%, +340 basis points (cc), mainly driven by higher net sales Q3 operating income grew +123% (cc, +106% USD); net income up +121% (cc, +111% USD)Q3 core EPS grew +20% (cc, +18% USD) to USD 2.06Q3 free cash flow1 of USD 6.0 billion (+18% USD) driven by higher net cash flows from operating activitiesStrong nine months performance with sales up +11% (cc, +9% USD) and core operating income up +20% (cc, +17% USD)Q3 selected innovation milestones: Kisqali FDA approval and positive CHMP opinion for HR+/HER2- stage II and III eBC Fabhalta FDA accelerated approval for IgANPluvicto FDA filing for pre-taxane mCRPC Full-year 2024 guidance raised2 Net sales expected to grow low double-digit (from high single to low double-digit)Core operating income expected to grow high teens (from mid to high teens) Basel, October 29, 2024 – commenting on Q3 2024 results, Vas Narasimhan, CEO of Novartis, said: “Novartis delivered another quarter of strong operational performance in Q3, with sales up 10% and core operating income up 20%. All key growth drivers contributed to the momentum. We achieved important indications expansions for Kisqali in early breast cancer and Fabhalta in IgA nephropathy, and we completed our PSMAfore filing for Pluvicto in the US. With the momentum in our business and pipeline, we were able to once again upgrade our full-year guidance and remain highly confident in our mid-term outlook.” Key figuresContinuing operations3 Q3 2024Q3 2023% change9M 20249M 2023% change USD m USD mUSDcc USD m USD mUSDccNet sales12 82311 782910 37 16434 017911Operating income3 6271 762106123 11 0147 1875361Net income3 1851 513111121 9 1195 9345462EPS (USD)1.580.73116127 4.502.845867Free cash flow5 9655 04318 12 61811 01915 Core operating income5 1454 4051720 14 63512 5511720Core net income4 1333 5851517 11 82210 3201518Core EPS (USD)2.061.741820 5.834.951821 1. Constant currencies (cc), core results and free cash flow are non-IFRS measures. An explanation of non-IFRS measures can be found on page 46 of the Interim Financial Report. Unless otherwise noted, all growth rates in this Release refer to same period in prior year. 2. Please see detailed guidance assumptions on page 7. 3. As defined on page 35 of the Interim Financial Report, Continuing operations include the retained business activities of Novartis, comprising the innovative medicines business and the continuing corporate activities and Discontinued operations include operational results from the Sandoz business.StrategyOur focus In 2023, Novartis completed its transformation into a “pure-play” innovative medicines business. We have a clear focus on four core therapeutic areas (cardiovascular-renal-metabolic, immunology, neuroscience and oncology), with multiple significant in-market and pipeline assets in each of these areas, that address high disease burden and have substantial growth potential. In addition to two established technology platforms (chemistry and biotherapeutics), three emerging platforms (gene & cell therapy, radioligand therapy and xRNA) are being prioritized for continued investment into new R&D capabilities and manufacturing scale. Geographically, we are focused on growing in our priority geographies – the US, China, Germany and Japan. Our priorities Accelerate growth: Renewed attention to deliver high-value medicines (NMEs) and focus on launch excellence, with a rich pipeline across our core therapeutic areas.Deliver returns: Continuing to embed operational excellence and deliver improved financials. Novartis remains disciplined and shareholder-focused in our approach to capital allocation, with substantial cash generation and a strong capital structure supporting continued flexibility. Strengthening foundations: Unleashing the power of our people, scaling data science and technology and continuing to build trust with society. Financials Following the September 15, 2023, shareholder approval of the spin-off of Sandoz, Novartis reported its consolidated financial statements as “continuing operations” and “discontinued operations.” Continuing operations include the retained business activities of Novartis, comprising the innovative medicines business and the continuing corporate activities. Discontinued operations include the Sandoz Division and selected portions of corporate activities attributable to Sandoz’s business, as well as certain expenses related to the spin-off. While the commentary below focuses on continuing operations, we also provide information on discontinued operations. Continuing operations Third quarter Net sales were USD 12.8 billion (+9%, +10% cc), with volume contributing 12 percentage points to growth. Generic competition had a negative impact of 2 percentage points and pricing was flat. Operating income was USD 3.6 billion (+106%, +123% cc), mainly driven by lower impairments and higher net sales, partly offset by higher R&D investments. Net income was USD 3.2 billion (+111%, +121% cc), mainly driven by higher operating income. EPS was USD 1.58 (+116%, +127% cc), benefiting from the lower weighted average number of shares outstanding. Core operating income was USD 5.1 billion (+17%, +20% cc), mainly driven by higher net sales, partly offset by higher R&D investments. Core operating income margin was 40.1% of net sales, increasing 2.7 percentage points (+3.4 percentage points cc). Core net income was USD 4.1 billion (+15%, +17% cc), mainly due to higher core operating income. Core EPS was USD 2.06 (+18%, +20% cc), benefiting from the lower weighted average number of shares outstanding. Free cash flow from continuing operations amounted to USD 6.0 billion (+18% USD), compared with USD 5.0 billion in the prior-year quarter, driven by higher net cash flows from operating activities from continuing operations. Nine months Net sales were USD 37.2 billion (+9%, +11% cc) with volume contributing 14 percentage points to growth. Generic competition had a negative impact of 2 percentage points and pricing had a negative impact of 1 percentage point. Operating income was USD 11.0 billion (+53%, +61% cc), mainly driven by higher net sales, lower impairments and restructuring charges, partly offset by prior-year one-time income from legal matters and higher R&D investments. Net income was USD 9.1 billion (+54%, +62% cc), mainly driven by higher operating income. EPS was USD 4.50 (+58%, +67% cc), benefiting from the lower weighted average number of shares outstanding. Core operating income was USD 14.6 billion (+17%, +20% cc), mainly driven by higher net sales, partly offset by higher R&D investments. Core operating income margin was 39.4% of net sales, increasing 2.5 percentage points (+3.2 percentage points cc). Core net income was USD 11.8 billion (+15%, +18% cc), mainly due to higher core operating income. Core EPS was USD 5.83 (+18%, +21% cc), benefiting from the lower weighted average number of shares outstanding. Free cash flow from continuing operations amounted to USD 12.6 billion (+15% USD), compared with USD 11.0 billion in the prior-year period, driven by higher net cash flows from operating activities from continuing operations. Discontinued operations Discontinued operations include the Sandoz generic pharmaceuticals and biosimilars division, certain corporate activities attributable to Sandoz and certain other expenses related to the spin-off of the Sandoz business. Third quarter As the Sandoz spin-off was completed on October 3, 2023, there were no operating results in the third quarter of 2024 related to discontinued operations. In the third quarter of 2023, discontinued operations net sales were USD 2.5 billion, operating loss amounted to USD 86 million and net income from discontinued operations was USD 250 million. For further details see Note 3 “Significant acquisition of businesses and spin-off of Sandoz business” and Note 11 “Discontinued operations” to the condensed interim consolidated financial statements. Nine months As the Sandoz spin-off was completed on October 3, 2023, there were no operating results in the first nine months of 2024 related to discontinued operations. In the first nine months of 2023, discontinued operations net sales were USD 7.4 billion, operating income amounted to USD 265 million and net income from discontinued operations was USD 440 million. For further details see Note 3 “Significant acquisition of businesses and spin-off of Sandoz business” and Note 11 “Discontinued operations” to the condensed interim consolidated financial statements. Total Company Third quarter Total Company net income was USD 3.2 billion in 2024, compared to USD 1.8 billion in 2023 and basic EPS was USD 1.58 compared to USD 0.85 in prior year quarter. Net cash flows from operating activities for total Company amounted to USD 6.3 billion and free cash flow amounted to USD 6.0 billion. Nine months Total Company net income was USD 9.1 billion in 2024, compared to USD 6.4 billion in 2023 and basic EPS was USD 4.50 compared to USD 3.05 in prior year. Net cash flows from operating activities for total Company amounted to USD 13.4 billion and free cash flow amounted to USD 12.6 billion. Q3 key growth drivers Underpinning our financial results in the quarter is a continued focus on key growth drivers (ranked in order of contribution to Q3 growth) including: Entresto(USD 1 865 million, +26% cc) sustained robust, demand-led growth, with increased penetration in the US and Europe following guideline-directed medical therapy in heart failure, as well as in China with increased penetration in hypertensionCosentyx(USD 1 693 million, +28% cc) sales grew mainly in the US, Europe and emerging growth markets, driven by recent launches (including the HS indication and the IV formulation in the US) and volume growth in core indicationsKisqali(USD 787 million, +43% cc) sales grew strongly across all regions, based on increasing recognition of its overall survival benefit in HR+/HER2- advanced breast cancer and Category 1 NCCN guidelines recommendationKesimpta(USD 838 million, +28% cc) sales grew reflecting increased demand for a high efficacy product with convenient self-administered dosing; the prior-year period benefited from a one-time revenue deduction adjustment in EuropePluvicto(USD 386 million, +50% cc) sales grew in the US and Europe. Q3 sales benefited from a one-time revenue deduction adjustment in Europe. With supply now unconstrained, the focus is on increasing share in established RLT sites, while opening new sites and referral pathways, and initiating new patientsLeqvio(USD 198 million, +119% cc) continued to show steady growth, with a focus on increasing account and patient adoption, and continuing medical educationJakavi(USD 500 million, +18% cc) sales grew across all regions driven by strong demand across indicationsScemblix(USD 182 million, +72% cc) sales grew across all regions demonstrating the continued high unmet need in CMLTafinlar + Mekinist(USD 534 million, +12% cc) sales grew mainly in the US and emerging growth markets, driven by increased demandXolair(USD 418 million, +15% cc) grew mainly in emerging growth markets and EuropeFabhalta(USD 44 million) launch continues in PNH with an approval in IgAN in Q3Ilaris(USD 372 million, +12% cc) sales grew across all regions, led by the US and EuropeLutathera(USD 190 million, +19% cc) sales grew across all regions due to increased demand and earlier line adoption (within indication) in the US and Japan Emerging Growth Markets*Grew +12% (cc) overall. China grew +18% (cc) to USD 1.0 billion, mainly driven by Entresto, Cosentyx and Leqvio *All markets except the US, Canada, Western Europe, Japan, Australia, and New Zealand Net sales of the top 20 brands in the third quarter and nine months Q3 2024 % change9M 2024 % change USD mUSDccUSD mUSD ccEntresto1 86526265 6422830Cosentyx1 69327284 5452425Kesimpta- excl. PY revenue deduction adjust. 838 285528562 27449614962Kisqali 78740432 1314548Promacta/Revolade 569-101 633-4-3Tafinlar + Mekinist 53411121 53179Jakavi 50017181 4491416Tasigna 419-10-91 260-10-9Xolair 41813151 2441517Ilaris 37211121 0961216Pluvicto- excl. revenue deduction adjust. 38651375036 1 04147424742Sandostatin Group 305-10-8 973-3-1Zolgensma 30801 95234Lucentis 245-33-32 834-29-28Exforge Group 174-7-4 544-21Lutathera 1901919 5341717Leqvio 198120119 531129130Scemblix 1827272 4826769Galvus Group 159-12-6 458-15-8Diovan Group 150-22 450-31Top 20 brands total10 292171829 6041719 R&D update - key developments from the third quarter New approvals Kisqali(ribociclib)FDA approved Kisqali with a broad indication for HR+/HER2- stage II and III early breast cancer (eBC) at high risk of recurrence, approximately doubling the population eligible for CDK4/6 inhibitor adjuvant therapy, with the inclusion of those without nodal involvement. In addition, the CHMP issued a positive opinion for Kisqali in eBC in October. Fabhalta(iptacopan)FDA granted accelerated approval to Fabhalta for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. Regulatory updates Pluvicto (lutetium Lu177 vipivotide tetraxetan)Completed FDA submission for Pluvicto pre-taxane mCRPC label expansion based on the positive Phase III PSMAfore study.Scemblix(asciminib)FDA granted Priority Review status to Scemblix for the treatment of newly diagnosed adult patients with Philadelphia chromosome-positive CML in chronic phase (Ph+ CML-CP). Scemblix is also under regulatory review in this indication in key international markets worldwide, including in China and Japan.Fabhalta(iptacopan)Submissions for the treatment of C3 glomerulopathy (C3G) completed in the EU, China and Japan. Results from ongoing trials and other highlights Kisqali(ribociclib)Results from a four-year post-hoc analysis of the pivotal Phase III NATALEE trial showed the addition of Kisqali to endocrine therapy (ET) in patients with stage II and III HR+/HER2- eBC reduced the risk of recurrence by 28.5% compared to ET alone. This invasive disease-free survival benefit was consistent across all pre-specified patient subgroups, including those with node-negative disease. Results were also consistent across secondary efficacy endpoints, with a trend for improvement in overall survival. Safety and tolerability remained consistent with previously reported results. Data presented at ESMO Congress 2024.Leqvio(inclisiran)In the Phase III V-MONO study, Leqvio demonstrated clinically meaningful and statistically significant low-density lipoprotein cholesterol (LDL-C) lowering versus both placebo and ezetimibe in patients who were at low or moderate risk of developing atherosclerotic cardiovascular disease (ASCVD) and not receiving lipid-lowering therapy. Novartis plans to present results from this trial at an upcoming medical meeting and share with regulatory agencies including FDA.Kesimpta(ofatumumab)Data from the ALITHIOS open-label extension study showed first-line Kesimpta treatment for up to six years led to less disability and disease progression in recently diagnosed (≤3 years) and treatment-naïve people with relapsing multiple sclerosis (RMS), compared to those who switched from teriflunomide.In the separate US-based single-arm OLIKOS Phase IIIb study, all clinically stable RMS patients who switched from intravenous anti-CD20 therapy to Kesimpta showed no new gadolinium-enhancing (Gd+) T1 lesions at 12 months. Data from both studies were presented at the ECTRIMS 2024 Annual Meeting.PelabresibBased on Novartis review of 48-week data from the Phase III MANIFEST-2 study, longer follow-up time is needed to determine, in consultation with Health Authorities, the regulatory path for pelabresib in myelofibrosis. We will continue to follow patients in MANIFEST-2 and evaluate the potential for additional studies to support registration. The 48-week data will be presented at an upcoming medical meeting.XXB750Novartis will not advance further development of XXB750 in resistant hypertension and heart failure, following current scientific assessment and review of available data from early investigational studies.BD&LNovartis, in collaboration with Versant Ventures, established Borealis Biosciences, an independent, discovery-stage biotechnology company focused on developing next-generation RNA-based medicines for kidney diseases. Under the agreement, Novartis has the option to acquire two future development-ready programs to augment its renal portfolio, a strategic area of focus for the company.Novartis entered into a collaboration agreement with Generate: Biomedicines to discover and develop protein therapeutics across multiple disease areas with generative AI. The collaboration will combine Generate’s AI platform with Novartis expertise and capabilities in target biology, biologics development, and clinical development to create novel therapeutics and to accelerate the pace of drug discovery and development. Capital structure and net debt Retaining a good balance between investment in the business, a strong capital structure, and attractive shareholder returns remains a priority. During the first nine months of 2024, Novartis repurchased a total of 52.7 million shares for USD 5.7 billion on the SIX Swiss Exchange second trading line. These purchases included 45.4 million shares (USD 4.8 billion) under the up-to USD 15 billion share buyback announced in July 2023 (with up to USD 7.9 billion still to be executed). In addition, 7.3 million shares (USD 0.9 billion) were repurchased to mitigate dilution related to participation plans of associates, with the remainder of repurchases for this purpose to be executed in Q4 2024. Further, 1.1 million shares (for an equity value of USD 0.1 billion) were repurchased from associates. In the same period, 9.1 million shares (for an equity value of USD 0.8 billion) were delivered as a result of share deliveries related to participation plans of associates. Consequently, the total number of shares outstanding decreased by 44.7 million versus December 31, 2023. These treasury share transactions resulted in an equity decrease of USD 5.0 billion and a net cash outflow of USD 5.5 billion. As of September 30, 2024, net debt increased to USD 16.3 billion compared to USD 10.2 billion net debt at December 31, 2023. The increase was mainly due to the free cash flow of USD 12.6 billion being more than offset by the USD 7.6 billion annual dividend payment, net cash outflow for M&A / intangible assets transactions of USD 5.5 billion, and cash outflow for treasury share transactions of USD 5.5 billion. As of Q3 2024, the long-term credit rating for the company is Aa3 with Moody’s Ratings and AA- with S&P Global Ratings. 2024 outlook Barring unforeseen events; growth vs prior year in ccPrevious guidanceNet salesExpected to grow low double-digit(from high single to low double-digit)Core operating incomeExpected to grow high teens(from mid to high teens) Key assumptions: We assume Tasigna, Promacta and Entresto US generic entry mid-2025 for forecasting purposes Foreign exchange impact If late-October exchange rates prevail for the remainder of 2024, the foreign exchange impact for the year would be negative 1 percentage point on net sales and negative 3 to negative 4 percentage points on core operating income. The estimated impact of exchange rates on our results is provided monthly on our website. Key figures1 Continuing operations2Q3 2024Q3 2023% change 9M 20249M 2023% change USD m USD mUSDcc USD m USD mUSDccNet sales12 82311 782910 37 16434 017911Operating income3 6271 762106123 11 0147 1875361As a % of sales28.315.0 29.621.1 Net income3 1851 513111121 9 1195 9345462EPS (USD)1.580.73116127 4.502.845867Cash flows from operating activities6 2865 30419 13 42611 67315 Non-IFRS measures
Free cash flow 5 9655 04318 12 61811 01915 Core operating income5 1454 4051720 14 63512 5511720As a % of sales40.137.4 39.436.9 Core net income4 1333 5851517 11 82210 3201518Core EPS (USD)2.061.741820 5.834.951821
Discontinued operations2Q3 2024Q3 2023% change 9M 20249M 2023% change USD m USD mUSDcc USD m USD mUSDccNet sales 2 476nmnm 7 428nmnmOperating (loss)/income -86nmnm 265nmnmAs a % of sales -3.5 3.6 Net income 250nmnm 440nmnmNon-IFRS measures
Core operating income 250nmnm 1 185nmnmAs a % of sales 10.1 16.0
Total CompanyQ3 2024Q3 2023% change 9M 20249M 2023% change USD m USD mUSDcc USD m USD mUSDccNet income3 1851 763nmnm 9 1196 374nmnmEPS (USD)1.580.85nmnm 4.503.05nmnmCash flows from operating activities6 2865 378nmnm 13 42611 911nmnmNon-IFRS measures
Free cash flow 5 9655 043nmnm 12 61811 038nmnmCore net income4 1333 784nmnm 11 82211 209nmnmCore EPS (USD)2.061.83nmnm 5.835.37nmnm nm=not meaningful 1. Constant currencies (cc), core results and free cash flow are non-IFRS measures. An explanation of non-IFRS measures can be found on page 46 of the Interim Financial Report. Unless otherwise noted, all growth rates in this Release refer to same period in prior year.2. As defined on page 35 of the Interim Financial Report, Continuing operations include the retained business activities of Novartis, comprising the innovative medicines business and the continuing corporate activities and Discontinued operations include operational results from the Sandoz business. Detailed financial results accompanying this press release are included in the Interim Financial Report at the link below:https://ml-eu.globenewswire.com/resource/download/6504f5e3-a14c-43ba-8b72-44dcc5a45156/ DisclaimerThis press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, that can generally be identified by words such as “may,” “can,” “will,” “continue,” “ongoing,” “grow,” “launch,” “expect,” “deliver,” “focus,” “address,” “accelerate,” “deliver,” “remain,” “scaling,” “guidance,” “outlook,” “long-term,” “priority,” “potential,” “momentum,” or similar expressions, or by express or implied discussions regarding potential new products, potential new indications for existing products, potential product launches, or regarding potential future revenues from any such products; or regarding results of ongoing clinical trials; or regarding potential future, pending or announced transactions; regarding potential future sales or earnings; or by discussions of strategy, plans, expectations or intentions, including discussions regarding our continued investment into new R&D capabilities and manufacturing; or regarding our capital structure; or regarding the consequences of the spin-off of Sandoz and our transformation into a “pure-play” innovative medicines company. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. You should not place undue reliance on these statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. Neither can there be any guarantee expected benefits or synergies from the transactions described in this press release will be achieved in the expected timeframe, or at all. In particular, our expectations could be affected by, among other things: uncertainties regarding the success of key products, commercial priorities and strategy; uncertainties in the research and development of new products, including clinical trial results and additional analysis of existing clinical data; uncertainties regarding the use of new and disruptive technologies, including artificial intelligence; global trends toward healthcare cost containment, including ongoing government, payer and general public pricing and reimbursement pressures and requirements for increased pricing transparency; uncertainties regarding our ability to realize the strategic benefits, operational efficiencies or opportunities expected from our external business opportunities; our ability to realize the intended benefits of our separation of Sandoz into a new publicly traded standalone company; our ability to obtain or maintain proprietary intellectual property protection, including the ultimate extent of the impact on Novartis of the loss of patent protection and exclusivity on key products; uncertainties in the development or adoption of potentially transformational digital technologies and business models; uncertainties surrounding the implementation of our new IT projects and systems; uncertainties regarding potential significant breaches of information security or disruptions of our information technology systems; uncertainties regarding actual or potential legal proceedings, including regulatory actions or delays or government regulation related to the products and pipeline products described in this press release; safety, quality, data integrity, or manufacturing issues; our performance on and ability to comply with environmental, social and governance measures and requirements; major political, macroeconomic and business developments, including impact of the war in certain parts of the world; uncertainties regarding future global exchange rates; uncertainties regarding future demand for our products; and other risks and factors referred to in Novartis AG’s most recently filed Form 20-F and in subsequent reports filed with, or furnished to, the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise. All product names appearing in italics are trademarks owned by or licensed to Novartis. About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide. Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram. Novartis will conduct a conference call with investors to discuss this news release today at 14:00 Central European time and 9:00 Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Novartis website. A replay will be available after the live webcast by visiting https://www.novartis.com/investors/event-calendar. Detailed financial results accompanying this press release are included in the condensed interim financial report at the link below. Additional information is provided on our business and pipeline of selected compounds in late-stage development. A copy of today's earnings call presentation can be found at https://www.novartis.com/investors/event-calendar. Important dates November 20-21, 2024Meet Novartis Management 2024 (London, UK)December 9, 2024Impact & Sustainability annual investor event (virtual)January 31, 2025 Fourth quarter & full year 2024 results Please find full media release in English attached and on the following link:Media Release (PDF) Further language version is available through the following link: German version is available through the following link:Medienmitteilung (PDF)
临床结果临床3期上市批准财报加速审批
100 项与 特立氟胺 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 复发-缓解型多发性硬化 | 欧盟 | 2013-08-26 | |
| 复发-缓解型多发性硬化 | 冰岛 | 2013-08-26 | |
| 复发-缓解型多发性硬化 | 列支敦士登 | 2013-08-26 | |
| 复发-缓解型多发性硬化 | 挪威 | 2013-08-26 | |
| 复发性多发性硬化 | 韩国 | 2013-07-18 | |
| 多发性硬化症 | 美国 | 2012-09-12 |
未上市
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 放射学孤立综合征 | 临床3期 | 法国 | 2017-09-25 | |
| 放射学孤立综合征 | 临床3期 | 法国 | 2017-09-25 | |
| 放射学孤立综合征 | 临床3期 | 瑞士 | 2017-09-25 | |
| 放射学孤立综合征 | 临床3期 | 瑞士 | 2017-09-25 | |
| 放射学孤立综合征 | 临床3期 | 土耳其 | 2017-09-25 | |
| 放射学孤立综合征 | 临床3期 | 土耳其 | 2017-09-25 | |
| 流感病毒感染 | 临床2期 | 奥地利 | 2011-09-01 | |
| 流感病毒感染 | 临床2期 | 加拿大 | 2011-09-01 | |
| 流感病毒感染 | 临床2期 | 德国 | 2011-09-01 | |
| 流感病毒感染 | 临床2期 | 俄罗斯 | 2011-09-01 |
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临床结果
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| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
临床3期 | 1,882 | (non-Hispanic Black) | 廠觸願窪窪憲鏇夢蓋壓(鏇鑰艱鹽夢夢網醖蓋齋) = 鏇顧獵蓋襯鏇鏇糧築淵 獵鏇艱顧鹽廠廠網觸憲 (獵齋築餘遞廠遞膚獵壓 ) | 积极 | 2024-07-17 | ||
(non-Hispanic Black) | 廠觸願窪窪憲鏇夢蓋壓(鏇鑰艱鹽夢夢網醖蓋齋) = 襯齋壓鹽範淵獵鏇餘願 獵鏇艱顧鹽廠廠網觸憲 (獵齋築餘遞廠遞膚獵壓 ) | ||||||
N/A | 784 | Teriflunomide (TFL) | 鹽積繭鏇憲積鬱醖鏇鑰(餘憲選遞積淵餘簾壓鏇): OR = 1.76 (95% CI, 1.11 ~ 2.81) | 积极 | 2024-04-09 | ||
Placebo | |||||||
临床4期 | 复发性多发性硬化 ABCG2 polymorphisms | - | 積窪鹽築憲積築選繭積(鏇鑰鹹遞遞選製鹹糧淵) = 糧觸糧遞鹹範願顧餘衊 鏇繭選觸夢壓窪餘憲觸 (觸鏇糧膚鑰鹽壓遞餘鹽, 769.0) 更多 | 积极 | 2024-02-05 | ||
(Variant ABCG2) | 積窪鹽築憲積築選繭積(鏇鑰鹹遞遞選製鹹糧淵) = 鑰積艱夢鑰鑰襯網鹽網 鏇繭選觸夢壓窪餘憲觸 (觸鏇糧膚鑰鹽壓遞餘鹽, 1053.0) 更多 | ||||||
N/A | anti-EBNA-1 | 101 | 壓糧構膚廠願淵蓋選齋(鬱獵顧憲製餘淵糧齋艱) = 蓋膚糧膚觸蓋膚遞構遞 鹽觸淵淵願顧願遞願網 (齋鹹艱淵積壓壓憲餘壓 ) 更多 | - | 2023-09-30 | ||
N/A | 34 | Teriflunomide rapid load (TRL) | 遞觸網製憲襯淵鹽醖壓(選廠範壓築鏇鑰鏇獵糧) = 鹽膚選選窪齋淵構遞顧 淵醖夢鬱積觸選襯艱顧 (鏇糧網鹽壓夢網遞鹹鹹 ) 更多 | 积极 | 2023-09-30 | ||
(Historical cohort) | 遞觸網製憲襯淵鹽醖壓(選廠範壓築鏇鑰鏇獵糧) = 壓觸廠窪廠積壓窪憲製 淵醖夢鬱積觸選襯艱顧 (鏇糧網鹽壓夢網遞鹹鹹 ) | ||||||
N/A | 720 | 顧觸顧鏇膚繭網網襯範(鏇廠壓壓醖齋範鹹餘鑰) = 願觸鏇糧糧製選製襯鏇 憲製蓋廠糧廠鹽糧衊鏇 (鏇觸醖製鹽淵膚齋獵鹽, 67.1 ~ 73.8) | - | 2023-09-30 | |||
N/A | 多发性硬化症 一线 | 110 | 鏇艱網壓襯窪蓋選選齋(憲簾鑰觸夢膚鬱廠蓋餘) = 衊憲構範夢選繭鏇鏇積 壓顧網製築鏇範顧鹹膚 (選糧製選築積憲廠壓夢, 0.09) 更多 | - | 2023-09-30 | ||
鏇艱網壓襯窪蓋選選齋(憲簾鑰觸夢膚鬱廠蓋餘) = 選壓選憲築窪築顧衊製 壓顧網製築鏇範顧鹹膚 (選糧製選築積憲廠壓夢, 0.05) 更多 | |||||||
N/A | 325 | 衊艱選憲鏇範網築鹹蓋(製鹹遞鏇醖繭襯鏇蓋衊) = DMT-naive experienced a greater and significant reduction (improvement) in psychological MSIS-29 score at month 24 compared to switch group 廠簾顧壓廠願襯艱築範 (窪憲壓願衊網淵製獵淵 ) | 积极 | 2023-04-25 | |||
临床3期 | 166 | 選醖顧願獵艱齋淵齋餘(構夢築鏇壓顧淵選糧膚) = 壓醖餘夢膚窪繭夢衊憲 餘窪糧齋製構壓衊構構 (襯簾築膚繭築觸範獵壓 ) | - | 2023-01-12 | |||
Placebo | 選醖顧願獵艱齋淵齋餘(構夢築鏇壓顧淵選糧膚) = 鏇淵網鏇顧廠膚鬱淵蓋 餘窪糧齋製構壓衊構構 (襯簾築膚繭築觸範獵壓 ) | ||||||
临床4期 | 55 | 衊餘襯鬱繭襯蓋簾鹹壓(獵積壓窪鑰製願獵願襯) = 構顧鏇齋餘鬱餘膚餘製 憲積積醖鹽艱鹹獵餘艱 (構醖窪簾鏇醖簾廠鏇觸, 餘鹹壓鹹鏇鏇窪淵鑰糧 ~ 簾獵衊淵鬱夢築製齋構) 更多 | - | 2022-10-20 |
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