With a prevalence of 2-4% in western countries, Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) is of major concern regarding its substantial impact on the social and physical quality of life. So far, endoscopic sinus surgery remains the treatment of choice when the first line of medical treatment with corticosteroid has failed.
During the last 15 years, several studies have shown that CRSwNP is associated with a T helper 2 (T2) immune response leading to B cell release of IgE, mucosal recruitment of eosinophils from bone marrow via Interleukin (IL)-5, IL-4 and IL-13 mediated chemoattractant production.
New biologic agents capable of blocking T2 cytokines have been developed in the field of eosinophil-associated diseases, shifting the paradigm of treatment for patients with CRSwNP. In the near future, endotype profiling with accurate biomarkers will be mandatory to tailor the treatment of nasal polyposis with specific biologic therapies.
Herein the investigators propose a prospective study monitoring medical records of CRSwNP patients who undergo biologic treatments. The objectives are to assess treatment efficacy on quality of life, to report clinical and biological criteria for prescription and to measure tolerance and compliance.Patient-reported outcomes will be addressed according to their initial clinical profile (allergy, asthma, NSAID, gastroesophageal reflux disease, obstructive apnea, otologic disorder, smoke habit).

开始日期2024-09-02

申办/合作机构-

NCT06572267 / Recruiting临床2期IIT

Safety and Efficacy of Meplazumab in Patients With Coronary Artery Disease: a Single-center, Triple-blinded, Placebo-controlled, Exploratory, Phase 2, Pilot Trial

The development of coronary atherosclerosis is closely related to inflammation, and CD147 may play an important role in its process. The present study was designed to evaluate the effects of long-term administration of mepolizumab (humanized anti-CD147 antibody) on lipid deposition and inflammation in coronary atherosclerotic plaques in patients with high-risk coronary artery disease, and to preliminarily explore the efficacy, safety, and dosage of long-term administration of mepolizumab in this population.

开始日期2024-08-26

申办/合作机构

西京医院第四军医大学

CTIS2023-508069-34-01 / RecruitingIIT

Biomarkers for the prediction of individual CRSwNP patients' responses to mepolizumab

开始日期2024-08-12

申办/合作机构-

100 项与美泊利珠单抗相关的临床结果

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100 项与美泊利珠单抗相关的转化医学

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100 项与美泊利珠单抗相关的专利（医药）

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1,311

项与美泊利珠单抗相关的文献（医药）

2025-01-01·JOINT BONE SPINE

Update on targeted treatments for ANCA-associated vasculitis

Article

作者: Puéchal, Xavier

Targeted therapy has revolutionized the management of ANCA-associated vasculitis (AAV) over the last fifteen years. Rituximab, an approved induction and maintenance agent for severe AAV, is no less effective than cyclophosphamide as induction therapy and particularly useful in relapsing or refractory disease, or in women. In patients with relapsing AAV, granulomatosis with polyangiitis or PR3-ANCA, it is more effective than cyclophosphamide. Rituximab maintenance is superior to the conventional immunosuppressive drugs that it replaces. Low-dose preemptive rituximab infusions are recommended every 6months for 18months, followed by re-evaluation to decide whether 4 additional biannual infusions should be administered, balancing the probability of relapse and the risk of serious infections on rituximab. A growing body of experimental and clinical data shows that C5a pathway inhibition is a promising therapeutic option for AAV, which could reduce glucocorticoids needs. Avacopan is a first approved oral C5A receptor antagonist, used when there is a high risk that glucocorticoids will cause serious adverse events. In eosinophilic granulomatosis with polyangiitis, the importance of IL-5 for eosinophil activation and survival led to evaluation and approval of mepolizumab, a humanized monoclonal antibody directed against IL-5. Mepolizumab showed a steroid-sparing effect. Its effectiveness in active vasculitis remains uncertain and is currently being evaluated. Benralizumab targeting the IL-5 receptor was recently shown to be noninferior to mepolizumab. Rituximab has had disappointing results in non-severe active vasculitis and is being evaluated as maintenance therapy. Plasma exchange is not indicated as first-line treatment but remains recommended when creatinine levels exceed 300μmol/L.

2024-12-31·Annals of medicine

Clinical characteristics of complete responders versus non-complete responders to omalizumab, benralizumab and mepolizumab in patients with severe asthma: a long-term retrospective analysis

Article

作者: Abad, Jorge ; Basagaña, Maria ; Carabias, Lídia ; Padró, Clara ; Pardo, Laura ; Roger, Albert ; Cardona Peitx, Gloria ; Rosell, Antoni ; Navarro, Juan ; Martínez-Rivera, Carlos ; Garcia-Olivé, Ignasi ; Cruz, Paula ; Martínez-Colls, Mimar

BACKGROUND:

Some patients with severe asthma may benefit from treatment with biologics, but evidence has been mostly collected from randomized controlled trials (RCTs), in which patients' characteristics are different from those encountered in asthma patients in the real-world setting. The aim of this study was to describe the clinical features of complete responders versus non-complete responders to long-term treatment with biologics in patients with severe asthma attended in routine daily practice.

METHODS:

Data of a cohort of 90 patients with severe asthma who were treated with biologics (omalizumab, benralizumab, and mepolizumab) for at least 12 months and were followed up to March 2022. Data recorded included clinical characteristics and effectiveness of treatment (exacerbation, Asthma Control Test [ACT] score, lung function, use of maintenance oral corticosteroids [mOCS]), FeNO, and blood eosinophils at baseline, at 12 months, and at the end of follow-up. Complete response is considered if, in addition to not presenting exacerbations or the use of mOCS, the ACT score was >20 and, the FEV₁ >80% predicted.

RESULTS:

An improvement in all asthma control parameters was observed after 12 months of treatment and a mean follow-up of 55 months. After 12 months of treatment 27.2% of patients met the criteria of complete response and this percentage even increased to 35.3% at the end of follow-up. Long-term complete response was associated to better lung function with mepolizumab and omalizumab treatment and to less previous exacerbations in the benralizumab group. The main cause of not achieving a complete response was the persistence of an airflow obstructive pattern.

CONCLUSIONS:

This study shows that omalizumab, benralizumab, and mepolizumab improved the clinical outcomes of patients with severe asthma in a clinic environment with similar effect sizes to RCTs in the long term follow-up. Airflow obstruction, however, was a predictor of a non-complete response to biologics.

2024-10-01·ANNALS OF ALLERGY ASTHMA & IMMUNOLOGY

Real-world unified airway benefits of mepolizumab

Article

作者: Deb, Arijita ; Packnett, Elizabeth ; Bernstein, Jonathan A ; Silver, Jared ; Lew, Carolyn R ; Robles, Yvonne

BACKGROUND:

Nasal polyps (NPs) are commonly associated with chronic rhinosinusitis (CRS). In keeping with the unified airway hypothesis, asthma and CRS with NP (CRSwNP) frequently co-occur, share a similar pathophysiology, and are often treated with oral corticosteroids (OCS); however, a need for alternative treatment options for patients with comorbid asthma and CRSwNP remains.

OBJECTIVE:

To characterize the short- and long-term dual airway effectiveness of the anti-interleukin-5 monoclonal antibody, mepolizumab, in real-world patients with asthma and comorbid NP.

METHODS:

Adult patients with CRSwNP who initiated mepolizumab from November 1, 2014, to September 30, 2021, were identified from 2 Merative MarketScan Research Databases. Outcomes were compared for the 12 months pre- and post-mepolizumab initiation and a variable follow-up period. Primary outcomes included the following: annual rate and proportion of patients with NP- and asthma-related exacerbations; NP surgery occurrences; all-cause OCS claims, number of OCS bursts, and daily OCS dose; all-cause and NP-related health care resource utilization.

RESULTS:

During the 12 months post-index, patients experienced fewer NP- and asthma-related exacerbations, required fewer sinus surgeries, and reduced use of OCS, with fewer all-cause OCS claims and OCS bursts. Significant reductions in asthma exacerbation-related and NP-related health care resource utilization were also observed.

CONCLUSION:

This study illustrated the near- and long-term real-world effectiveness of mepolizumab treatment, with a focus on dual lower and upper airway benefit from single-agent add-on therapy. These results may aid physicians in clinical decision-making for patients with asthma and comorbid CRSwNP with complex care needs.

173

项与美泊利珠单抗相关的新闻（医药）

2024-09-19

·CPHI制药在线

收藏 | 从重磅药物排名看小分子与单抗药物在肿瘤学和免疫学的未来

关注并星标CPHI制药在线 2024年Q2财报显示出了肿瘤学与免疫学产品的一个巨大差异，而且是趋势越来越明显的差异，即肿瘤学超级重磅炸弹基本上是小分子与单抗药物平分秋色的局面，而免疫学则基本上成为了单抗和蛋白的天下。 1. 肿瘤学与免疫学重磅药物模态分化 2024年第二季度销售额前十名的肿瘤学产品见表1。Keytruda仍然无可撼动地雄霸着销售榜首的位置。肿瘤学产品前十名中出现了六款小分子药物的身影，剩下的四个名额被单抗药物瓜分（图1）。从销售额的层面来看，得益于Keytruda优秀的表现，前十名中的单抗类肿瘤学药物的销售额达到136.9亿美元，占据62%份额，六款小分子肿瘤学药物的销售总额为84.6亿美元，占比38%（图2）。表1. 2024年Q2销售额排名前十的肿瘤学产品图1. 2024 Q2肿瘤学Top10药物模态数量图。图2. 2024 Q2肿瘤学Top10药物模态销售额。与肿瘤学小分子和单抗药物几乎平分秋色形成鲜明对比的是，2024年Q2免疫学Top10的队列几乎完全是单抗和蛋白“溥天之下，莫非王土”的局面（表2）。销售额排名前十的免疫学药物中有7款为单抗类药物，2款为融合蛋白，只有一款小分子药物跻身该榜单（图3），即艾伯维的新贵Rinvoq（Upadacitinib）。这款Janus 激酶小分子抑制剂药物2019年8月才获得FDA的批准，如今已经打进免疫类药物销售额的前十名。在2024年第二季度收获了14.3亿美元的销售收入，而且同比增长高达56%，表现非常强劲。然而Rinvoq在免疫类产品中只是一个孤例，即便我们把榜单扩大到15名，Rinvoq依然是唯一一款小分子免疫药物，因为11至15名均为单抗类药物（Tremfya（强生，9.1亿美元）、Taltz（礼来，8.2亿美元）、Actemra（罗氏，7.4亿美元）、Nucala（GSK，6.1亿美元）、Simponi（强生， 5.4亿美元））。从销售额的角度来看，作为孤例的小分子药物Rinvoq的销售额仅占前十名总额的7%，而蛋白与单抗则分别占据了11%和82%的份额，对小分子免疫药物形成了压倒性的优势。表2. 2024年Q2销售额排名前十的免疫学产品图3. 2024 Q2免疫学Top10药物模态数量图。图4. 2024 Q2肿瘤学Top10药物模态销售额。 2. 肿瘤学与免疫学药物重磅药物组成成分小分子和单抗的阵营都可能孕育出免疫学和肿瘤学重磅药物。肿瘤学重磅药物 ● 小分子药物：通常是激酶抑制剂，针对癌细胞生存和增殖所必需的特定突变或通路。例如诺华的imatinib (Gleevec) 和基因泰克的erlotinib (Tarceva)。 ● 单抗：这些药物针对癌细胞上的特定抗原。例如默沙东的Keytruda和百时美施贵宝的Opdivo。 ● ADCs：小分子药物和单抗结合的产物，将单抗与细胞毒性药物结合，提供靶向化疗。例如基因泰克的ado-trastuzumab emtansine (Kadcyla)。 ● CAR-T细胞疗法：涉及修改患者的T细胞，使其能够更好地识别和攻击癌细胞。例如Kite Pharma的Yescarta (axicabtagene ciloleucel)。免疫学重磅药物 ● 单抗：常用于中和参与自身免疫反应的特定细胞因子或细胞表面蛋白，例如艾伯维的Humira (adalimumab)。 ● 融合蛋白：工程化的蛋白质，通过模仿天然抑制剂来抑制免疫反应，例如安进/辉瑞的etanercept (Enbrel)。 ● 小分子药物：这些药物包括干扰免疫反应信号通路的JAK抑制剂，例如辉瑞的tofacitinib (Xeljanz)。 3. 肿瘤学与免疫学重磅药物模态组成何以出现分化肿瘤学和免疫学领域的重磅药物在治疗的模式上往往有所不同，这是由于它们所针对的疾病性质和所需的作用机制不同所致。他们的主要差异表现在以下几个方面： ✓ 靶点特异性：肿瘤学药物通常针对癌细胞特有的突变或蛋白质，而免疫学药物则针对免疫系统的成分以调节其活性。 ✓ 作用机制：肿瘤治疗可能涉及直接的细胞毒性作用或通过免疫系统调节来攻击癌细胞，而免疫学治疗主要集中在减少不适当的免疫反应。 ✓ 治疗目标：在肿瘤学中，目标通常是消除癌细胞或显著减少肿瘤负担。而在免疫学中，目标是控制或防止自身免疫和炎症反应。这些差异反映了癌症与自身免疫疾病的基本病理生理学差异，以及有效管理这些疾病所需的治疗策略。免疫学与肿瘤学中单克隆抗体和小分子药物的应用差异可以归因于与疾病性质、所需作用机制以及治疗目标相关的多种因素。免疫学重磅药物 ● 靶向特异性和调节 ✓ 精确性：单克隆抗体具有高度的特异性，能够精确靶向并调节免疫系统的特定成分，如细胞因子或细胞表面受体。在治疗自身免疫性疾病时，这种精确性尤为重要，因为目标是减弱过度活跃的免疫反应，而不广泛抑制免疫系统。 ✓ 长半衰期：单克隆抗体通常具有较长的半衰期，这对于需要持续调节免疫系统的慢性疾病治疗非常有利。例如，adalimumab（Humira）和infliximab（Remicade）等药物通过靶向TNF-alpha来减少自身免疫疾病中的炎症反应。 ● 作用机制 ✓ 阻断特定通路：单抗可以阻断与疾病病理相关的特定免疫通路。例如，通过靶向IL-4受体α，单抗可以有效减少哮喘和特应性皮炎等疾病中的炎症反应。 ✓ 免疫调节：单抗可以调节免疫检查点或其他调节通路，以恢复免疫系统的平衡，如靶向IL-8或OX40受体的药物。肿瘤学重磅药物 ● 多样化的机制和靶点 ✓ 广泛的靶点范围：小分子药物可以靶向多种细胞内通路和蛋白质，包括参与细胞增殖、凋亡和DNA修复的那些。这种多样性在肿瘤学中至关重要，因为癌细胞通常具有多种突变和失调的通路。 ✓ 口服生物利用度：许多小分子药物可以口服给药，这相比于单克隆抗体需要的注射给药更加方便。这可以提高患者的依从性和生活质量。 ● 快速作用和代谢 ✓ 快速起效：小分子药物通常具有较快的起效时间，这在快速进展的癌症中至关重要。例如，酪氨酸激酶抑制剂如imatinib（Gleevec）可以迅速抑制致癌激酶的活性。 ✓ 代谢灵活性：小分子药物代谢和排泄更快，便于剂量调整和副作用管理。 ● 组合疗法： ✓ 协同作用：小分子药物经常与其他疗法（包括单克隆抗体和化疗）联合使用，以实现协同效果。例如，将小分子抑制剂与免疫检查点抑制剂结合，可以增强抗肿瘤反应。总的来说，单抗的精确性、特异性和持续作用使其在调节自身免疫疾病的免疫系统中表现出色。小分子药物的多样性、快速作用以及能够靶向广泛细胞内通路的特性，使其在癌症治疗中至关重要。这种差异反映了自身免疫疾病与癌症之间不同的治疗需求和生物学复杂性，推动了免疫学中优先使用单克隆抗体，而肿瘤学中则偏好小分子药物。 4. 小分子药物在免疫疗法开发中是否成为明日黄花免疫学领域的趋势确实显示出单抗和其他生物制剂在逐渐取代小分子药物。这一变化可以归因于以下几个因素： ● 疗效和特异性前文提到，单抗体具有高度的特异性，能够精确靶向并调节免疫系统的特定成分，这种属性在治疗自身免疫性疾病时尤为重要。 ● 生物类似药的竞争生物类似药的推出表明单抗市场非常强劲。新上市的生物类似药不仅将夺取品牌生物制剂的市场份额，其相对低廉的价格也同样可能侵蚀小分子免疫药物的销售额。 ● 新批准和新适应症像赛诺菲的Dupixent这样的单抗持续获得FDA批准用于额外的适应症，进一步巩固了这些单抗药物的市场地位。 ● 开发商投资意愿制药公司正在大力投资于生物制剂的开发和商业化，因为这些药物具有高效性并能够获得高定价。公司将其研发管线重点放在生物制剂上，这些药物有望带来高回报并享有更长的价格决定期。 ● 小分子药物的挑战 ✓ 免疫调节的复杂性：免疫调节的复杂性通常需要生物制剂所具备的高特异性和定制化作用，而小分子药物可能无法如此有效地实现这些功能。 ✓ 法规和开发难题：开发能够安全有效地调节免疫系统且无脱靶效应或毒性的小分子药物极具挑战性，这导致生物制剂在这一治疗领域中更受青睐。尽管小分子药物将在免疫学领域继续发挥作用，尤其是在口服给药和快速起效具有优势的领域，但趋势表明单抗和其他生物制剂将在免疫学的重磅药物市场中占据主导地位。生物制剂的精确性、高效性以及有利的市场动态正推动这一转变，使得小分子药物在免疫学领域的重磅药物中变得越来越罕见。虽然生物制剂主导免疫学重磅药物已经成为了不争的事实，但小分子药物似乎并没有成为彻底的明日黄花。它们的内在优势仍然可以使小分子药物成为免疫学领域的重要组成，就像Rinvoq的表现那样。小分子药物持续优势可以表现在以下几个方面： ✓ 口服生物利用度：小分子药物通常可以口服给药，具有更高的患者便利性和依从性。这在慢性病和需要长期治疗的疾病中尤为重要。 ✓ 细胞内靶点：小分子药物能够进入细胞内部，靶向细胞内的蛋白质和信号通路。 ✓ 快速起效和灵活性：小分子药物通常具有快速的起效时间，并且由于其代谢和排泄速度较快，可以更灵活地调整剂量，这在治疗某些急性或快速进展的疾病时尤其有用。 ✓ 开发成本和时间：相比于生物制剂，小分子药物的开发成本和时间通常较低。生物制剂的开发往往涉及复杂的生物工程和生产过程，而小分子药物的合成更为直接，允许更快的药物开发周期。尽管生物制剂目前在免疫疗法中占据主导地位，但小分子药物仍然在不断创新，探索新的治疗途径。例如，小分子免疫调节剂正在研究中，试图通过调节特定的免疫信号通路来增强或抑制免疫反应。这类药物可能在未来的免疫疗法中发挥更大的作用。此外，小分子药物与生物制剂的组合疗法正在成为一种有前途的策略。这种组合可以充分利用两类药物的优势，例如，通过小分子药物快速靶向细胞内通路，同时使用生物制剂调节特定的免疫反应，从而实现更为全面的治疗效果。 5. 小分子药物在肿瘤学产品开发中的未来尽管单抗和细胞疗法等生物制剂在癌症治疗中日益突出，小分子药物在肿瘤学领域的前景依然广阔。这是由小分子肿瘤学药物内在的优势所决定的： ● 靶向细胞内通路小分子药物能够穿透细胞膜，靶向细胞内的蛋白质和通路，而这些是较大的生物制剂往往无法接触到的。这种能力对于抑制激酶、转录因子以及其他与癌细胞增殖和生存有关的细胞内靶点至关重要。 ● 口服给药许多小分子药物可以制成口服剂型，相较于可注射的生物制剂，提供了更大的便利性，并提高了患者的依从性。这对需要长期治疗的慢性癌症尤其有利。 ● 快速开发和审批与生物制剂相比，小分子药物的开发和监管审批过程通常更快，因为生物制剂通常需要更复杂的生产和验证过程。这可以加速新疗法的上市。 ● 精准医疗基因组学和分子生物学的进步正在推动小分子药物的发展，这些药物可以靶向癌细胞中的特定基因突变和分子异常。 ● 组合疗法小分子药物越来越多地与其他治疗方法结合使用，包括免疫疗法和传统化疗，以增强疗效并克服耐药性。例如，将小分子抑制剂与免疫检查点抑制剂结合使用，可以改善抗肿瘤反应。 ● 下一代抑制剂针对以前被认为是“不可药物化”蛋白质（如KRAS）的下一代小分子抑制剂的开发是一个重要的研究领域。小分子药物在共价抑制剂、分子胶和PROTACs等领域的开发为小分子肿瘤学产品开拓了崭新的天地。 ● 表观遗传调节剂小分子药物能够调节表观遗传调控因子，如组蛋白去乙酰化酶（HDAC）抑制剂和DNA甲基转移酶抑制剂，正在探索其逆转癌细胞中异常基因表达模式的潜力。小分子药物在肿瘤学中的未来前景光明，这得益于其独特的优势、持续的创新以及癌症治疗领域不断演变的格局。尽管生物制剂和其他先进疗法将继续发挥重要作用，但小分子药物仍将是肿瘤治疗武器库中的关键组成部分，为各种癌症提供靶向性、便利性和有效的治疗选择。 6. 展望展望未来，小分子药物和单克隆抗体在肿瘤学与免疫学中的应用将继续朝着高度专业化和分化的方向发展。小分子药物在肿瘤学中的角色将更加集中于精准靶向特定基因突变和信号通路，尤其是在癌症中难以利用大分子药物直接靶向的细胞内过程。这类药物在克服耐药性和开发组合疗法方面也将发挥更大的作用，进一步推动个性化癌症治疗的发展。与此同时，单克隆抗体在免疫学领域的主导地位将进一步巩固和扩展。未来，单抗药物将更加多样化和复杂化，如双特异性抗体和抗体药物偶联物，将继续优化其在自身免疫病和炎症性疾病中的应用。由于单抗能够精确调节免疫系统的特定成分，它们在治疗复杂免疫紊乱方面的潜力将不断扩大。此外，基于单抗的创新疗法，如融合蛋白和新型免疫调节剂，也将在免疫学中占据更重要的地位。随着这两类药物在各自领域内的持续发展，肿瘤学和免疫学中的治疗方法将更加个性化和精准。未来的治疗策略可能会越来越依赖于这种模式的分化趋势，通过结合小分子药物和单克隆抗体的优势来开发更为有效和耐受性更好的联合治疗方案，从而为患者提供更全面的治疗选择。 Ref. Regeneron Reports Second Quarter 2024 Financial and Operating Results. Regeneron Press Release. 01. 08. 2024. AbbVie Reports Second-Quarter 2024 Financial Results. AbbVie Press Release. Retrieved on 31. 08. 2024. Takeda Earnings Call Analysis. Takeda Press Release. Retrieved on 31. 08. 2024. Bristol Myers Squibb Reports Second Quarter Financial Results for 2024. BMS Press Release. 26. 07. 2024. Top 15 Immunology Medicines by Q2 2024 Sales. Maven Bio. 29. 08. 2024. Hopkins, C. Keytruda Sales Climb 16 Percent in Q2 as Merck Pursues New Oncology Candidates. Precision Medicine Online. 30. 07. 2024. Gil, B. Johnson & Johnson's cancer drug Darzalex could replace Stelara as its best-seller. Quartz. 17. 07. 2024. AstraZeneca H1 and Q2 Results. AZ Press Release. 25. 07. 2024. Bristol Myers Squibb Reports Second Quarter Financial Results for 2024. BMS Press Release. 26. 07. 2024. Pfizer Reports Strong Second-Quarter 2024 Results And Raises 2024 Guidance. Pfizer Press Release. 30. 07. 2024. Johnson & Johnson reports Q2 2024 results. J&J Press Release. 17. 07. 2024. AbbVie Reports Second-Quarter 2024 Financial Results. AbbVie Press Release. 25. 07. 2024. END END END END 【智药研习社直播预告】来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，请关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~

免疫疗法财报

2024-09-19

·BioSpace

AstraZeneca Wins Rare Autoimmune Indication for Asthma Biologic Fasenra

iStock, Robert Way With the FDA’s approval, Fasenra will compete with GSK’s Nucala, which in December 2017 became the first biologic approved for eosinophilic granulomatosis with polyangiitis. The FDA on Wednesday signed off on the expansion of AstraZeneca ’s Fasenra (benralizumab) for the treatment of rare autoimmune condition eosinophilic granulomatosis with polyangiitis. According to the pharma, the approval was supported by data from the Phase III MANDARA trial, which pit Fasenra against GSK’s Nucala (mepolizumab), previously the only approved therapy for eosinophilic granulomatosis with polyangiitis (EGPA). Patients with refractory or relapsing disease were given either 30 mg of Fasenra or 300 mg of Nucala monthly for 52 weeks. Results showed that Fasenra could match GSK’s biologic, eliciting a 59% remission rate versus 56% in the Nucala arm. The difference of 3 percentage points did not meet the statistical bar for superiority but was enough to establish the non-inferiority of Fasenra. Duration of remission was also comparable between groups. More patients in the Fasenra group were able to completely taper off of oral corticosteroid treatment, with 41% qualifying for withdrawal versus 26% in the Nucala group. Fasenra’s safety in MANDARA was consistent with its known profile. Ruud Dobber, executive vice president of AstraZeneca’s biopharma business unit, in a statement said Wednesday’s approval “demonstrates the potential of Fasenra to help patients suffering from eosinophilic disease beyond severe asthma” and will allow doctors in the U.S. “to offer an important new, convenient single monthly subcutaneous injection” to EGPA patients. Afflicting 15,000 patients in the U.S., EGPA is a rare and autoimmune condition characterized by the inflammation of small to medium blood vessels. Patients with this disease often experience weight loss, muscle and joint pain, rashes, extreme fatigue and shortness of breath, among other symptoms. In its more severe forms, EGPA can damage several organs across the body including the heart, gastrointestinal tract and lungs. If left unchecked, the condition can prove deadly. Patients are usually treated using high-dose oral corticosteroids, but tapering these down can lead to relapses. Before Fasenra’s approval, the only biologic for EGPA was GSK’s Nucala, which was approved for this indication in December 2017 . According to AstraZeneca, around half of patients fail to reach remission with current treatments. Fasenra is a humanized IgG1 monoclonal antibody that targets the IL-5 receptor, plays an important role in the inflammatory cascade. The FDA first signed off on the biologic in November 2017 for severe eosinophilic asthma in patients aged 12 years and older. Recently, AstraZeneca secured a crucial expansion to Fasenra’s label for the treatment of younger children aged six to 11 years.

上市批准临床3期临床结果

2024-09-19

·Pharmaceutical Technology

AstraZeneca’s Fasenra to challenge GSK’s Nucala in rare vasculitis after FDA nod

Fasenra generated $1.55bn last year, according to AstraZeneca’s financials. Image credit: Alexanderstock23 / Shutterstock. AstraZeneca ‘s Fasenra (bevacizumab) is set to challenge GSK ’s Nucala (mepolizumab) in eosinophilic granulomatosis with polyangiitis (EGPA) as the US Food and Drug Administration (FDA) approved the former. The approval was based on a non-inferiority Phase III MANDARA trial (NCT04157348) comparing Fasenra to Nucala in patients with EGPA. GSK’s Nucala was first approved by the FDA in 2015, and it has since been the only FDA-approved biologic therapy, along with corticosteroids, for EGPA. Fasenra is a monoclonal antibody that inhibits IL-5 alpha on eosinophils, a type of white blood cell, to induce cell death. The drug was first developed by Japanese company BioWa and has since been licensed to AstraZeneca. This is the third indication the FDA has approved for Fasenra. The therapy is approved as an add-on maintenance therapy for patients with severe asthma and uncontrolled severe eosinophilic asthma . Nucala is approved by the FDA for five indications – severe asthma, EGPA, severe eosinophilic asthma , hypereosinophilic syndrome, and chronic rhinosinusitis with nasal polyps. The two had comparable sales last year, with Nucala pulling in slightly higher sales of £1.6bn ($2.19bn), compared to $1.55bn in sales for Fasenra, according to respective companies’ financials. GlobalData expects Fasenra and Nucala to have comparable sales by 2029, generating $2.3bn and $2.1bn, respectively. See Also: Pioneering ePRO and eCOA innovations for next-generation clinical trials GlobalData is the parent company of Pharmaceutical Technology . The Phase III MANDARA trial enrolled 140 patients with EGPA. The study met its primary endpoint with 59% of participants in the Fasenra arm achieving remission at weeks 36 and 48, compared with 56% for Nucala. Furthermore, 41% of the patients in the Fasenra group were able to eliminate corticosteroids from their treatment plan, compared to 26% in the Nucala group. AstraZeneca is also investigating Fasenra in additional autoimmune conditions, including chronic obstructive pulmonary disease (COPD) . However, the therapy failed to meet primary endpoints in Phase II and Phase III trials for various dermatological indications such as atopic dermatitis, bullous pemphigoid, chronic spontaneous urticaria, and eosinophilic esophagitis. Earlier this month, GSK announced that the Phase III MATINEE trial (NCT04133909) evaluating Nucala in COPD met its primary endpoint. While the company did not disclose data from the study, it noted that there was a “statistically significant and clinically meaningful reduction” between the two treatment groups of up to two years.

临床3期上市批准临床结果临床2期

100 项与美泊利珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D04923	美泊利珠单抗	R03DX09	DB06612

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
肉芽肿伴多血管炎	中国	GlaxoSmithKline Trading Services Ltd.	2021-11-19
嗜酸性肉芽肿	日本	GSK Plc	2020-03-25
嗜酸性粒细胞性哮喘	韩国	GSK Plc	2016-04-01
慢性鼻窦炎伴鼻息肉	欧盟	GlaxoSmithKline Trading Services Ltd.	2015-12-01
慢性鼻窦炎伴鼻息肉	冰岛	GlaxoSmithKline Trading Services Ltd.	2015-12-01
慢性鼻窦炎伴鼻息肉	列支敦士登	GlaxoSmithKline Trading Services Ltd.	2015-12-01
慢性鼻窦炎伴鼻息肉	挪威	GlaxoSmithKline Trading Services Ltd.	2015-12-01
Churg-Strauss综合征	欧盟	GlaxoSmithKline Trading Services Ltd.	2015-12-01
Churg-Strauss综合征	冰岛	GlaxoSmithKline Trading Services Ltd.	2015-12-01
Churg-Strauss综合征	列支敦士登	GlaxoSmithKline Trading Services Ltd.	2015-12-01
Churg-Strauss综合征	挪威	GlaxoSmithKline Trading Services Ltd.	2015-12-01
高嗜酸性粒细胞综合征	欧盟	GlaxoSmithKline Trading Services Ltd.	2015-12-01
高嗜酸性粒细胞综合征	冰岛	GlaxoSmithKline Trading Services Ltd.	2015-12-01
高嗜酸性粒细胞综合征	列支敦士登	GlaxoSmithKline Trading Services Ltd.	2015-12-01
高嗜酸性粒细胞综合征	挪威	GlaxoSmithKline Trading Services Ltd.	2015-12-01
肺嗜酸性粒细胞增多	欧盟	GlaxoSmithKline Trading Services Ltd.	2015-12-01
肺嗜酸性粒细胞增多	冰岛	GlaxoSmithKline Trading Services Ltd.	2015-12-01
肺嗜酸性粒细胞增多	列支敦士登	GlaxoSmithKline Trading Services Ltd.	2015-12-01
肺嗜酸性粒细胞增多	挪威	GlaxoSmithKline Trading Services Ltd.	2015-12-01
哮喘	美国	GlaxoSmithKline LLC	2015-11-04

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
嗜酸粒细胞增多症	临床3期	英国	GSK Plc	2020-09-07
嗜酸粒细胞性食管炎	临床3期	中国	GSK Plc	2018-08-29
重度哮喘	临床3期	中国	GlaxoSmithKline Trading Services Ltd.	2018-08-29
重度哮喘	临床3期	中国	葛兰素史克（中国）投资有限公司	2018-08-29
鼻息肉	临床3期	美国	GSK Plc	2017-05-25
鼻息肉	临床3期	阿根廷	GSK Plc	2017-05-25
鼻息肉	临床3期	澳大利亚	GSK Plc	2017-05-25
鼻息肉	临床3期	加拿大	GSK Plc	2017-05-25
鼻息肉	临床3期	德国	GSK Plc	2017-05-25
鼻息肉	临床3期	荷兰	GSK Plc	2017-05-25

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适应症

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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


NCT04133909 (MATINEE, NEWS) 人工标引	临床3期	慢性阻塞性肺疾病	-	Nucala	艱顧艱夢鏇夢構觸簾觸(遞醖製網衊衊構築壓範) = The trial met its primary endpoint. 鑰衊蓋願齋繭衊構醖壓 (夢夢餘窪簾網窪衊憲醖 ) 达到更多	积极	2024-09-06
				Placebo
EULAR2024 人工标引	N/A	嗜酸性肉芽肿 interleukin 5 (IL-5) \| IL-5α receptor	67	Mepolizumab 300 mg	繭鹽顧獵選築壓齋蓋鹹(窪積觸衊蓋鹹壓膚廠積) = 獵繭夢膚糧網糧繭憲繭醖廠廠壓憲觸鹹願窪願 (簾鬱網淵鹽壓顧簾範餘 ) 更多	积极	2024-06-05
				Mepolizumab 100 mg	繭鹽顧獵選築壓齋蓋鹹(窪積觸衊蓋鹹壓膚廠積) = 選繭膚願淵鬱膚簾衊網醖廠廠壓憲觸鹹願窪願 (簾鬱網淵鹽壓顧簾範餘 ) 更多
EULAR2024 人工标引	N/A	Churg-Strauss综合征维持 \| 诱导 IL-5	48	Mepolizumab (maintenance phase for relapsing and refractory EGPA)	餘繭繭憲選糧鑰築遞廠(糧築鬱鹹鬱淵網網餘憲) = 鹽鹽鹽簾窪鑰醖膚積壓鬱衊鹽獵淵鬱憲憲鹹鑰 (夢壓糧餘範觸壓網壓憲 ) 更多	积极	2024-06-05
				Mepolizumab (in the remission induction phase for severe EGPA)	餘繭繭憲選糧鑰築遞廠(糧築鬱鹹鬱淵網網餘憲) = 夢艱網夢齋夢選遞鹽簾鬱衊鹽獵淵鬱憲憲鹹鑰 (夢壓糧餘範觸壓網壓憲 ) 更多
EULAR2024	N/A	Churg-Strauss综合征	-	Mepolizumab 300mg	鏇鹽鬱選選餘膚製簾鑰(壓鹽糧衊築鑰壓廠艱膚) = A total of 118 patients were enrolled, 91% completed the study and 9% discontinued treatment. Of these, 55% were female, the mean (standard deviation [SD]) age was 62 (13.2) years and the mean (SD) time since diagnosis was 5.6 (4.4) years. Over 99% of patients had comorbidities at baseline (28% osteoporosis; 22% hypertension; 15% hyperlipidemia). Most patients (97%) used 300mg mepolizumab with a mean (SD) duration of 4.2 (0.68) years during the treatment period; 2 patients who continued from the MIRRA trial (NCT04551989) used mepolizumab for ≤7.4 years. AEs were reported in 69 patients (58%) and SAEs were reported in 26 patients (22%) over the observation period, infections were the most commonly reported (AEs: 36 patients [31%]; SAEs: 8 patients [7%]). There were no drug-related AEs. 齋廠艱鹽餘齋憲壓糧醖 (遞糧淵鬱鹹鑰鑰網蓋夢 )	-	2024-06-05
EULAR2024	N/A	Churg-Strauss综合征维持 MPO-ANCA-associated vasculitis (MPO-AAV)	25	MEPOLIZUMAB (Early administration group)	醖獵窪顧鑰齋鬱衊壓顧(鹹積齋艱窪鏇齋繭選鏇) = 0 in both groups 製製襯齋鏇夢製網鹽壓 (獵願壓蓋鏇蓋醖鏇簾獵 ) 更多	积极	2024-06-05
				MEPOLIZUMAB (During maintenance group)
NCT03298061 (LAP/MEA116841, ATS2024) 人工标引	临床3期	肉芽肿伴多血管炎	100	Mepolizumab	構鬱窪廠鏇範膚鏇觸膚(衊襯醖淵觸遞衊鹽鑰鑰) = 壓鬱觸齋鹹淵鹽衊壓簾壓醖餘獵選顧鬱窪觸遞 (繭糧窪襯蓋憲齋顧憲憲 )	积极	2024-05-19
EHA2024	N/A	高嗜酸性粒细胞综合征二线 PDGFRΑ-negative	3	Mepolizumab	廠膚衊餘鹽鏇衊廠觸獵(糧範鏇醖壓蓋壓艱製顧) = 廠壓遞衊觸積壓蓋夢觸顧夢衊膚餘積願繭廠鬱 (鬱觸衊淵鹽選鬱選繭廠 )	积极	2024-05-14
NCT03298061 (MEA116841 \| LAP/MEA116841, CTgov)	临床3期	Churg-Strauss综合征	100	Mepolizumab	鑰積衊餘憲獵壓醖遞獵(膚夢獵繭構範艱觸壓鹽) = 衊選鏇鹹膚遞範選艱膚願願鹹艱醖鑰構壓選餘 (衊鬱鬱網憲遞糧獵憲鹹, 淵醖構顧糧積壓蓋襯壓 ~ 壓壓憲製獵願簾糧選壓) 更多	-	2024-03-12
Pubmed \| J Allergy Clin Immunol	N/A	IL-5-driven eosinophilia	5	Mepolizumab 700 mg intravenously monthly for 3 months	網齋鬱鬱廠鏇衊顧遞衊(網願範獵顧醖餘衊艱鬱) = 醖齋蓋製積夢憲網鹽壓願鏇憲鹽顧鏇構膚構夢 (遞鹹膚齋衊齋齋襯鏇衊 )	不佳	2024-03-01
				Mepolizumab 300 mg subcutaneously monthly	網齋鬱鬱廠鏇衊顧遞衊(網願範獵顧醖餘衊艱鬱) = 繭鹹窪製築鏇窪積觸網願鏇憲鹽顧鏇構膚構夢 (遞鹹膚齋衊齋齋襯鏇衊 )
AAAAI2024 人工标引	N/A	重度哮喘	15	Mepolizumab	築積範廠衊餘窪蓋衊鏇(觸鑰願範壓襯選顧鏇顧) = 廠醖繭糧糧網蓋醖醖構遞築觸壓壓餘糧膚鹹積 (獵遞鹹繭構鬱構築繭醖 ) 更多	积极	2024-02-23