Dupixent approved in the US as the first-ever biologic medicine for patients with COPD         Dupixent is indicated for the approximately 300,000 adults in the US with inadequately controlled COPD and an eosinophilic phenotype Following recent approvals in the EU and China, the US approval is based on two landmark phase 3 studies that showed Dupixent achieved significant reduction in exacerbations, and also showed improvements in lung function and health-related quality of life compared to placeboDupixen ...

文章核心观点 - 美国FDA批准了Dupixent作为成人不能控制的慢性阻塞性肺病(COPD)的加用维持治疗,这是首个获批的生物制剂 [2][3] - Dupixent在两项III期临床试验中显示可显著降低中重度急性加重,改善肺功能和生活质量 [3] - Dupixent是目前所有适应症中新处方量最多的生物制剂,也是美国肺科医生最常开具的生物制剂 [1] 根据目录分类总结 COPD疾病概况 - COPD是一种损害肺部并导致肺功能逐步下降的呼吸系统疾病,是全球第四大死因 [7] - COPD的主要症状包括持续性咳嗽、大量痰液分泌和呼吸困难,可能影响日常活动能力,导致睡眠障碍、焦虑和抑郁 [7] - COPD与严重的健康和经济负担有关,主要由于反复发生需要使用糖皮质激素和/或抗生素治疗的急性加重 [7][8] Dupixent COPD适应症 - Dupixent适用于约30万名美国存在不能控制的COPD且伊奥辛性表型的成人患者 [1][8] - 伊奥辛性表型患者发生急性加重的风险增加约30%,1年内COPD相关再住院风险也增加 [8] Dupixent COPD III期临床试验 - BOREAS和NOTUS两项III期临床试验评估了Dupixent相比安慰剂在中重度COPD伊奥辛性表型患者中的疗效和安全性 [8][9] - 与安慰剂相比,Dupixent组患者在52周内中重度急性加重的年化率分别降低30%和34% [3] - Dupixent组患者在12周和52周时肺功能(呼气量)改善幅度分别比安慰剂组高74 mL和68 mL [3] - Dupixent组患者在52周时生活质量改善(SGRQ量表4分以上)的比例分别为51%,高于安慰剂组的43%和47% [3] Dupixent安全性 - Dupixent的安全性总体与既往适应症一致,最常见的不良反应包括上呼吸道感染、头痛、鼻咽炎等 [4] - 胆囊炎发生率Dupixent组为0.6%,安慰剂组为0.1% [4]

Approval follows EU approval of Dupixent for adults with COPD with raised blood eosinophils, and is based on two landmark Phase 3 trials showing Dupixent significantly reduced exacerbations, improved lung function and also improved health-related quality of life COPD is the most prevalent chronic respiratory disease in China, and is a priority within the government’s Healthy China 2030 public health plan Dupixent is now approved in four indications across respiratory and dermatological diseases in China TA ...

Dupixent approved in China as the first-ever biologic medicine for patients with COPD Approval follows EU approval of Dupixent for adults with COPD with raised blood eosinophils, and is based on two landmark phase 3 studies showing Dupixent significantly reduced exacerbations, improved lung function, and also improved health-related quality of lifeCOPD is the most prevalent chronic respiratory disease in China, and is a priority within the government’s Healthy China 2030 public health plan Dupixent is now a ...

文章核心观点 - 公司将于2024年10月31日发布第三季度财务和经营业绩报告 [1] - 公司将在当天上午8:30举行电话会议和网络直播 [2] - 公司是一家领先的生物技术公司,专注于研发和商业化治疗严重疾病的创新药物 [3][4] 公司概况 - 公司拥有多项获批上市的治疗药物和在研产品管线,涵盖眼科、过敏和炎症、肿瘤、心血管代谢、神经系统、血液、传染病和罕见病等领域 [3] - 公司利用自主研发的技术平台,如VelociSuite®,不断推动科学发现和加快药物开发 [4] - 公司还利用Regeneron Genetics Center®的数据洞见和基因医学平台,发现创新靶点和潜在治疗方法 [4]

Chief District Judge Thomas Kleeh denied Regeneron Pharmaceuticals, Inc.‘s REGN effort to prevent the sale of Amgen Inc‘s AMGN Eylea biosimilar.Regeneron filed a notice of its appeal to the U.S. Court of Appeals for the Federal Circuit.The appeal is from the Order issued on September 23, 2024, which denied Regeneron’s request for a preliminary injunction, along with any related orders, decisions, rulings, findings, or conclusions connected to that Order.Reuters highlighted that an Amgen spokesperson express ...

文章核心观点 - 欧洲药品管理局(CHMP)建议批准杜普利单抗(Dupixent)用于治疗1-11岁儿童的嗜酸性食管炎(EoE),这将是该年龄段首个获批的EoE治疗药物[1][2] - 在EoE KIDS III期临床试验中,接受杜普利单抗治疗的儿童在第16周时有更高比例达到组织学缓解,且疗效持续至1年[2] - 杜普利单抗在儿童EoE患者中的安全性与成人和青少年患者一致,常见不良反应包括COVID-19、恶心、注射部位疼痛和头痛[3] 关于EoE - EoE是一种慢性、进行性的疾病,与2型炎症相关,可损害食管功能[4] - EoE诊断困难,症状可能被误认为其他疾病,诊断存在延迟[4] - EoE严重影响儿童进食能力,可能导致呕吐、腹痛、吞咽困难、食欲下降和生长发育受阻[4] - 需要持续管理EoE以降低并发症和疾病进展的风险[4] 关于杜普利单抗 - 杜普利单抗是一种完全人源单克隆抗体,通过抑制IL-4和IL-13通路发挥作用,不是免疫抑制剂[5] - 杜普利单抗在多项III期临床试验中显示显著的临床获益和2型炎症降低[5] - 杜普利单抗已在60多个国家获批用于多种适应症,全球已有超过100万患者使用[5] 关于Regeneron的VelociImmune技术 - Regeneron的VelociImmune技术利用基因改造的人源化免疫系统小鼠平台生产优化的全人源抗体[6][7] - Regeneron利用VelociImmune技术开发了多款FDA批准的全人源单克隆抗体药物[7] 杜普利单抗的开发计划 - 杜普利单抗由Regeneron和赛诺菲共同开发,已在60多项临床试验中涉及1万多名患者[8] - 除已获批适应症外,Regeneron和赛诺菲正在研究杜普利单抗治疗其他2型炎症或过敏性疾病的潜在用途[8]

文章核心观点 - 欧洲药品管理局(CHMP)建议批准杜普利单抗(Dupixent)用于治疗1岁及以上儿童的嗜酸性食管炎(EoE) [1] - 这是基于一项III期临床试验结果,显示接受杜普利单抗治疗的儿童组织学缓解率显著高于安慰剂组 [2] - 如获批准,杜普利单抗将成为欧盟首个获批用于该年龄段EoE患者的药物 [1] 关于EoE - EoE是一种慢性、进行性的疾病,与2型炎症有关,可损害食管功能 [4] - 诊断困难,症状可能被误认为其他疾病,导致诊断延迟 [4] - EoE可严重影响儿童进食能力,还可能导致呕吐、腹痛、吞咽困难、食欲下降等 [4] - 需要持续管理以降低并发症和疾病进展的风险 [4] 关于杜普利单抗 - 杜普利单抗是一种完全人源单克隆抗体,可抑制IL-4和IL-13通路 [5] - III期临床试验证实其在多种相关且常合并的疾病中具有显著的临床获益和降低2型炎症的作用 [5] - 已在60多个国家获批用于多种适应症,全球已有超过100万患者使用 [5] 研发计划 - 杜普利单抗由Sanofi和Regeneron共同开发 [6] - 已在60多项临床试验中研究,涉及1万多名患有各种2型炎症驱动性疾病的患者 [6] - 除已获批适应症,公司还在研究其用于治疗未知原因的慢性瘙痒和疱疹样天疱疮等其他适应症 [7] 公司介绍 - Regeneron是一家领先的生物技术公司,专注于研发治疗严重疾病的创新药物 [8][9] - Sanofi是一家创新型全球医疗保健公司,致力于通过科学创新改善人们的生活 [10]

Following Priority Review, Dupixent is now available to patients as young as 12 years with inadequately controlled CRSwNP Current treatment options leave many patients with uncontrolled disease and often result in the recurrence of nasal polyps Dupixent is the leading biologic medicine for all five FDA-approved indications in new-to-brand prescriptions TARRYTOWN, N.Y. and PARIS, Sept. 13, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food an ...

Three new post-hoc analyses highlight EYLEA HD rapid and sustained fluid control and consistent safety profile over two years in patients with wet age-related macular degeneration (wAMD) New indirect comparison evaluates disease control of EYLEA HD and faricimab across different pivotal Phase 3 trials in wAMD TARRYTOWN, N.Y., Sept. 11, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced new analyses of EYLEA HD® (aflibercept) Injection 8 mg and EYLEA® (aflibercept) Injec ...