Tezepelumab

After over a decade without notable progress in treating chronic obstructive pulmonary disease, patients with this ongoing condition now have two new treatment options, with more expected in the future. Regeneron and Sanofi recently revealed that the FDA has expanded the approved uses of their widely successful drug DUPIXENT to include COPD treatment. This marks the drug's sixth approved indication in the US, following its first approval seven years ago for atopic dermatitis. LAS VEGAS, Nov. 12, 2024 /PRNewswire/ -- Chronic obstructive pulmonary disease (COPD) is a progressive lung condition characterized by obstructed airflow, making breathing difficult. It primarily encompasses two main conditions: chronic bronchitis and emphysema, often coexisting. COPD typically develops due to long-term exposure to irritants such as cigarette smoke, air pollution, or occupational dust. As per DelveInsight analysis, the diagnosed prevalent population of COPD in the 7MM was around 44 million in 2023. These cases of COPD in the 7MM are expected to increase at a significant CAGR of 1.4% throughout the study period (2020–2034). As per the estimates, the majority of cases of COPD are in females as compared to males, in the US. But in EU4 and the UK, and Japan the diagnosed cases of males represent the majority of the cases. Overall, in the 7MM, females are predominantly high in number. In 2023, the US had around 3 million, 9 million, 5 million, and 1 million cases of GOLD 1, GOLD 2, GOLD 3, and GOLD 4, respectively based on the severity of airflow limitation. Estimates suggest that airflow limitation was higher in GOLD 2 severity. Various types of medications are used to manage COPD symptoms and complications, including bronchodilators, which help relax the muscles around the airways. This relaxation opens the airways and makes breathing easier. Most bronchodilators are administered via an inhaler. In more severe cases, the inhaler may also contain steroids to reduce inflammation. Some commonly used short-acting and long-acting bronchodilators for COPD management include Albuterol (ProAir HFA, Ventolin HFA, and others), Ipratropium (Atrovent HFA), Levalbuterol (Xopenex), Aclidinium (Tudorza Pressair), Arformoterol (Brovana), and Formoterol (Perforomist). In the LABA category, medications such as Striverdi Respimat, Arcapta/Onbrez, Serevent, and Brovana are included, while the LAMA class features drugs like Spiriva (available as Spiriva HandiHaler and Spiriva Respimat), Tudorza Pressair, Incruse Ellipta, Yupelri, Seebri Neohaler, and Lonhala Magnair. Since the generic version of Brovana was approved in April 2020, its market share has declined. Additionally, Arcapta Neohaler, Seebri Neohaler, and Utibron Neohaler were discontinued in the US in March 2020, which means they no longer contribute to market size. Patients who do not respond to single therapies are often prescribed double or triple therapy. Among the double therapies, the LABA+ICS combination is widely recommended, with drugs such as Symbicort, Breo Ellipta, and Advair. There are also LABA+LAMA combinations, including Anoro Ellipta, Stiolto Respimat, and Bevespi Aerosphere. In July 2020, the US FDA approved AstraZeneca's BREZTRI AEROSPHERE for the maintenance treatment of patients with COPD. Additionally, in October 2020, TRIXEO AEROSPHERE (a combination of formoterol fumarate, glycopyrronium bromide, and budesonide) received marketing authorization in the EU for the maintenance treatment of adult patients with moderate to severe COPD who are not adequately controlled by either a combination of an ICS and LABA or a LABA and LAMA. Currently, two triple combination therapies are available in the US: BREZTRI and TRELEGY ELLIPTA. Learn more about the FDA-approved COPD drugs @ Drugs for COPD Treatment Recently, Sanofi/Regeneron Pharmaceuticals' DUPIXENT added one more jewel to its crown by getting a label expansion nod for COPD from the FDA, EU, and NMPA. DUPIXENT's approval as the first targeted therapy for COPD represents a significant advancement in the treatment landscape for the disease. Unlike conventional treatments, which largely aim to manage symptoms, DUPIXENT specifically targets the IL-4 and IL-13 pathways linked to type 2 inflammation, a key driver in a subset of COPD patients. This precision in targeting allows for a more tailored treatment, especially for patients with elevated eosinophils, who often experience more frequent exacerbations and worse outcomes. The Phase III BOREAS trial demonstrated that patients treated with DUPIXENT experienced a 30% reduction in moderate-to-severe exacerbations over 52 weeks, significant improvements in lung function, and enhanced quality of life. By Week 52, those on DUPIXENT had improved prebronchodilator FEV1 by 160 mL compared to 77 mL in the placebo group. DUPIXENT was also well-tolerated, with a low frequency of adverse events. These results suggest that DUPIXENT could drastically shift COPD management by reducing exacerbations, improving lung function, and offering a safer, targeted therapy for patients with type 2 inflammation. To know more about COPD treatment options, visit @ New Treatment for COPD The chronic obstructive pulmonary disease pipeline possesses potential drugs in mid-stage developments to be launched in the near future. Itepekimab (Sanofi/Regeneron Pharmaceuticals), Benralizumab (AstraZeneca), Tezepelumab (Amgen/AstraZeneca), Mepolizumab (GSK), and others shall further create a positive impact on the market. Discover which therapies are expected to grab major COPD market share @ COPD Market Report Itepekimab is a fully human monoclonal antibody that targets interleukin-33 (IL-33), a protein involved in both type 1 and type 2 inflammation. The drug is administered via subcutaneous injection. Preclinical studies demonstrated that REGN3500 effectively inhibited several markers of both inflammatory types. Regeneron and Sanofi are investigating REGN3500 in diseases related to respiratory and dermatological inflammation. Currently, REGN3500 is in a Phase III clinical trial for COPD and was developed using Regeneron's VelocImmune technology, which produces optimized fully human antibodies. The development is part of a global collaboration between Regeneron and Sanofi. FASENRA (benralizumab) is a humanized recombinant monoclonal antibody of the IgG1k immunoglobulin type that selectively targets the alpha chain of the interleukin 5 receptor (IL-5R) found on eosinophils and basophils. It prevents IL-5 from binding and stops the hetero-oligomerization of the IL-5R's alpha and beta subunits, thereby inhibiting signal transduction. Additionally, it is an afucosylated IgG, which enhances its affinity for the FcγRIIIα receptor on natural killer cells, macrophages, and neutrophils. Approved by the FDA in November 2017 for severe eosinophilic asthma, benralizumab was developed by MedImmune, AstraZeneca's global biologics R&D division. The company is currently conducting Phase III clinical trials for FASENRA as a treatment for COPD. TEZSPIRE (tezepelumab), a pioneering human monoclonal antibody created by Amgen and AstraZeneca, has shown considerable therapeutic potential for various respiratory conditions. Originally intended for treating COPD, TEZSPIRE has yielded encouraging results in decreasing moderate-to-severe exacerbations in patients with high blood eosinophil counts. Recent findings from the Phase IIa COURSE Trial, unveiled at the ATS 2024 conference, underscored TEZSPIRE's effectiveness in minimizing COPD exacerbations among patients with different eosinophil levels. Mepolizumab is currently undergoing Phase III clinical trials for COPD, particularly in patients with frequent exacerbations and elevated eosinophil levels. It is available as an injectable solution and a powder for reconstitution for subcutaneous administration. The IL-5 receptor complex activates several signaling pathways that lead to the release of cytokines, neuromediators, chemokines, and various kinases, which facilitate eosinophil differentiation, proliferation, recruitment, and degranulation. Mepolizumab works by inhibiting the formation of the IL-5 receptor complex, thereby preventing eosinophil activation. This disruption affects normal eosinophil maturation and function, leading to decreased eosinophilic airway inflammation and reduced eosinophil survival. Discover more about drugs for COPD in development @ COPD Clinical Trials The anticipated launch of these emerging therapies for COPD are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the COPD market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for COPD in the 7MM is expected to grow from USD 16 billion in 2023 with a significant CAGR of 5% by 2034. This growth is mainly driven by the rise in the number of prevalent cases of COPD, ongoing clinical research, and better diagnostic tools that might improve the prognosis of the disease. DelveInsight's latest published market report titled as Chronic Obstructive Pulmonary Disease Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the COPD country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The COPD market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Diagnosed Prevalent Cases of COPD Subtype-specific Diagnosed Prevalent Cases of COPD Gender-specific Diagnosed Prevalent Cases of COPD Age-specific Diagnosed Prevalent Cases of COPD Diagnosed Prevalent Cases of COPD Based on Severity of Airflow Limitation Diagnosed Prevalent Cases of COPD Based on Symptoms and Exacerbation History The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM COPD market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this COPD market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the COPD market. Also, stay abreast of the mitigating factors to improve your market position in the COPD therapeutic space. Related Reports Chronic Obstructive Pulmonary Disease Pipeline Chronic Obstructive Pulmonary Disease Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key COPD companies, including Sanofi, Chiesi Farmaceutici S.p.A., United Therapeutics Corporation, Verona Pharma plc, Immunotek, Yungjin Pharm. Co., Ltd., Pulmotect, Inc., Tetherex Pharmaceutical, CSL Behring, AstraZeneca, Novartis, Genentech, Vertex Pharmaceuticals, EmeraMed, Afimmune, Mereo BioPharma, Synairgen, Adamis Pharmaceuticals, Quercegen Pharmaceuticals LLC, Regend Therapeutics, Meridigen Biotech Co., Ltd., Pulmatrix, Eisai, GlaxoSmithKline, EpiEndo Pharmaceuticals, 3SBio, OmniSpirant, Foresee Pharmaceuticals, Amgen, Organicell Regenerative Medicine, Arrowhead Pharmaceuticals, ProterixBio, RS BioTherapeutics, MitoRx, C4X Discovery, Respiratorius, ARK biosciences, Incannex, GNI Pharma, Celon pharma, Alveolus Bio, Kinaset therapeutics, Landos Biopharma, Parion Sciences, KeyMed Biosciences, Bioneer corporation, AlgiPharma, Palobiofarma, Dimerix Bioscience, Glenmark Pharmaceuticals, among others. Asthma Market Asthma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key asthma companies including GlaxoSmithKline, 4D Pharma plc, AstraZeneca, Suzhou Connect Biopharmaceuticals, Avillion, Pearl Therapeutics, ARS Pharmaceuticals, Sinomab, Avalo Therapeutics, Kymab, Sanofi, Cumberland Pharmaceuticals, Genentech, Inc. , among others. Asthma Pipeline Asthma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products, and the key asthma companies, including Jiangsu Hengrui Medicine, GlaxoSmithKline, Immunotek SL, AB Science, EMS, Avalo Therapeutics, Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd., ARS Pharmaceuticals, Sanofi, Zura Bio Ltd., AstraZeneca, EURRUS Biotech GmbH, T-Balance Therapeutics GmbH, Gossamer Bio, Aldeyra Therapeutics, Inc., Trio Medicines, Janssen Research & Development, Arrowhead Pharmaceuticals, Hoffman-La-Roche, GlaxoSmithKline, Biohaven Pharmaceutical, TAK-Circulator Co., Shanghai Hengrui Pharmaceutical, among others. Acute Respiratory Distress Syndrome Market Acute Respiratory Distress Syndrome Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key ARDS companies, including MediciNova, Edesa Biotech, Light Chain Biosciences, Boehringer Ingelheim, Genentech, Windtree Therapeutics, Biomarck Pharmaceuticals, Athersys, Healios, Direct Biologics, Biohaven Pharmaceutical, Arch Biopartners, APEPTICO Forschung und Entwicklung GmbH, Staidson (Beijing) Biopharmaceuticals, Veru, Mesoblast Limited, Avalo Therapeutics, Pluristem Therapeutics, ILTOO Pharma, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

11月12日，阿斯利康公布2024Q3业绩，前三季度总营收391.82亿美元（+19%），其中产品收入375.76亿美元（+19%）。 从地区分布来看，前三季度美国市场收入167.03亿美元（+20%），新兴市场收入105.41亿美元（+23%），其中中国区收入50.49亿美元（+15%），超越默沙东成为中国市场收入第一的跨国药企。 2024前三季度跨国药企营收情况（单位：亿美元） 注：1.默沙东中国区制药收入为45.30亿美元； 2.赛诺菲制药业务收入已排除消费者健康业务（Opella）收入； 3.GSK收入按官方换算数据登记； 4.强生、辉瑞、艾伯维、GSK、BMS、吉利德、拜耳未公布中国区收入，无法统计； 5.罗氏仅公布中国区增长情况，未公布具体收入； 6.勃林格未公布2024Q3收入，无法统计； 7.汇率换算：1欧元=1.09美元，1瑞士法郎=1.1404美元，1丹麦克朗=0.14581美元。 从疾病领域来看，肿瘤业务、CVRM（心血管、肾脏及代谢）业务、罕见病业务、呼吸与免疫（R&I）业务、疫苗与免疫（V&I）业务以及其他业务在前三季度分别贡献了160.09亿美元（+22%）、93.79亿美元（+21%）、63.91亿美元（+14%）、57.50亿美元（+24%）、8.11亿美元（-12%）和8.43亿美元（-4%）的收入。 肿瘤业务收入对阿斯利康整体营收的贡献度最大，占比达到41%。Tagrisso（奥希替尼）、Imfinzi（度伐利尤单抗）、Calquence（阿可替尼）、Lynparza（奥拉帕利）、Enhertu（德曲妥珠单抗）、Zoladex（戈舍瑞林）、Imjudo（替西木单抗）等几款产品保持着两位数的增长。 Tagrisso（奥希替尼）和Imfinzi（度伐利尤单抗）是阿斯利康在肿瘤领域打造的两款拳头产品，凭借着治疗线数的前移和适应症的扩大，其销售额仍在高速增长中。值得一提的是，Tagrisso还在今年9月成为了第一款可在III期非小细胞肺癌（NSCLC）患者中应用的EGFR-TKI。 明星ADC产品Enhertu（德曲妥珠单抗）保持着突出的表现，同比增长达到60%。这是因为Enhertu今年又拿下了3项新的适应症，包括HER2+实体瘤、二线治疗HER2+乳腺癌和二线治疗HER2+胃或胃食管交界腺癌。截至目前，Enhertu已覆盖5类肿瘤，包括HER2+乳腺癌、HER2+胃或胃食管交界腺癌、HER2低表达乳腺癌、激活HER2突变非小细胞肺癌和HER2+实体瘤。未来，Enhertu还将覆盖HER2超低表达乳腺癌。 阿斯利康在ADC赛道即将迎来另一款重磅产品——TROP2 ADC德达博妥单抗。该产品已在今年申报上市，目前已申报3项适应症：二线治疗非鳞状NSCLC、二/三线治疗HR+/HER2-乳腺癌和EGFR突变型NSCLC。不过，德达博妥单抗用于二线治疗非鳞状NSCLC的适应症已在今日撤回。 此外，作为目前唯一一款AKT抑制剂，Truqap（capivasertib）也有不错的表现，上市不到一年即为阿斯利康带来了2.67亿美元的收入。 CVRM（心血管、肾脏及代谢业务部）是阿斯利康业绩的第二大支柱，前三季度收入主要由Farxiga（达格列净）贡献。目前，Farxiga覆盖了2型糖尿病、慢性肾病、心衰三大类常见慢性疾病，这三个领域有着庞大且持续的市场需求。今年6月，Farxiga还获批扩大人群至10岁及以上2型糖尿病患者，这将助推其销售额达到新的高度。达格列净的化合物专利虽已于2023年到期，但其制剂专利和晶型专利仍在有效期内（2027-2028）。目前，中国已有十余款达格列净片剂仿制药获批。 阿斯利康对CVRM非常重视，从去年到今年已在该领域达成多项大额交易，例如18亿美元收购CinCor。今年第三季度，阿斯利康仍在出手，在10月初以20.20亿美元的总交易额引进了石药集团的临床前在研降脂药。 罕见病业务和呼吸与免疫（R&I）业务对阿斯利康整体营收的贡献度相当。在二代C5单抗Ultomiris（瑞利珠单抗）发力之后，罕见病业务收入在2023年超过了R&I业务，趋势仍在保持中。今年，Ultomiris还将达到新的里程碑：年销售额超过一代C5单抗Soliris（依库珠单抗），并有望刷新C5单抗的峰值销售额纪录。 阿斯利康在罕见病领域还有一款增长潜力极大的产品Koselugo（司美替尼）也在发力中。Koselugo已上市4年，但仍是神经纤维瘤领域唯一一款针对性疗法，不过目前仅适用于2岁及以上的儿童患者。值得祝贺的是，今日阿斯利康还宣布司美替尼在针对成人神经纤维瘤的III期KOMET研究中取得了积极结果，其适用人群将进一步扩大。 R&I业务收入目前虽然落后于罕见病业务，但Tezspire（tezepelumab）、Saphnelo（阿伏利尤单抗）和Breztri（布地奈德/格隆溴铵/福莫特罗）四款产品已进入发力期，尤其是Tezspire，未来该业务收入仍然有可能反超罕见病业务。 Tezepelumab是目前唯一一款上市的TSLP单抗，为重度哮喘患者提供了IL-4和IL-5这类白介素靶向药物之外的治疗选择。从去年到今年，Tezspire的销售额实现了飞跃式增长，去年其全年销售额仅为1.35亿美元（不包括安进部分收入），而今年前三季度这一数字达到了4.71亿美元，今年加入十亿美元分子俱乐部已无悬念（加上安进报告的收入，今年前三季度Tezspire总收入为8.43亿美元）。鉴于TSLP在呼吸疾病领域有着不俗的治疗潜力，其他药企也加入了这一赛道，包括恒瑞医药、正大天晴、康诺亚等公司，共9款产品处于II期阶段。 2024第四季度及2025年，阿斯利康将迎来如下图所示的里程碑事件： 基于前三季度的表现，阿斯利康再次上调了全年业绩增长预期，从半年报时预计的中十位数增长调整至高十位数增长。 推荐阅读 诺和诺德2024Q3：司美格鲁肽前三季度大卖206亿美元，GLP-1药物中国收入8.32亿美元 默沙东2024Q3：K药前三季度收入216亿美元，HPV疫苗中国需求减少 BMS 2024Q3：新产品增长强劲，CD19 CAR-T疗法翻倍 度普利尤单抗前三季度收入突破百亿美元 罗氏2024Q3：眼科双抗Vabysmo超30亿美元，增长79%！中国区收入增长8% 艾伯维2024Q3：Skyrizi增长50.8%，接棒Humira 礼来2024Q3：替尔泊肽前三季度大卖110亿美元 诺华2024Q3：核药前三季度收入破10亿美元，降脂药Leqvio翻倍增长 辉瑞2024Q3：肿瘤业务增长31%，上调全年收入指引 Copyright © 2024 PHARMCUBE. All Rights Reserved. 欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。 免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。