文章核心观点 - 欧洲委员会批准了Dupixent作为成人不受控制的慢性阻塞性肺病(COPD)的新治疗方法 [1] - Dupixent是COPD治疗10多年来首个新的治疗方法 [1][8] - Dupixent可以显著降低COPD急性加重发作、改善肺功能和生活质量 [2][3][4] 根据目录分别总结 COPD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 [8] - 主要症状包括持续性咳嗽、大量痰液分泌和呼吸困难 [8] - 吸烟和接触有害颗粒物是COPD的主要危险因素 [9] - 过去10多年来COPD治疗方法没有新的突破 [9] Dupixent COPD III期临床试验 - BOREAS和NOTUS是两项随机、双盲、安慰剂对照的III期临床试验 [10][11][12][13] - 试验共入组1874名40-80岁的中重度COPD患者 [10] - 主要评估终点为52周内中重度COPD急性加重发作的年化率 [12] - 次要终点包括肺功能改善、生活质量改善以及安全性 [13] Dupixent疗效结果 - Dupixent组患者较安慰剂组分别有30%和34%的中重度COPD急性加重发作率降低 [2] - Dupixent组患者肺功能(FEV1)较基线改善160毫升和139毫升,优于安慰剂组 [3] - Dupixent组患者生活质量(SGRQ评分)较基线有统计学显著改善 [4] - 上述疗效在不同亚组(吸烟状态、基线肺功能、急性加重史等)中均有体现 [5] Dupixent安全性 - Dupixent的安全性总体与既往适应症一致 [6][7] - 常见不良反应包括注射部位反应、结膜炎、关节痛等 [6][7]

NEW YORK, July 2, 2024 /PRNewswire/ -- Kuehn Law, PLLC, a shareholder litigation law firm, is investigating whether certain officers and directors of Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) breached their fiduciary duties to shareholders. The investigation concerns potential self-dealing. Shareholders may be entitled to damages and corporate governance reforms.If you own REGN please contact Justin Kuehn, Esq. by email at [email protected] or call (833) 672-0814. The consultation and case are free wit ...

Regeneron Pharmaceuticals, Inc. (REGN) announced that the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) has recommended approval of oncology candidate odronextamab.The CHMP adopted a positive opinion recommending conditional marketing authorization of odronextamab to treat adults with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy.A final decision from the European Comm ...

NEW YORK, June 30, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”) (NASDAQ: REGN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Regeneron and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. [Click here for information about joining the class action ...

TARRYTOWN, N.Y., June 28, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional marketing authorization of odronextamab to treat adults with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy. The European Commission is expected to ann ...

TARRYTOWN, N.Y., June 28, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional marketing authorization of odronextamab to treat adults with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy. The European Commission is expected to anno ...

TARRYTOWN, N.Y., June 27, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that it will report its second quarter 2024 financial and operating results on Thursday, August 1, 2024, before the U.S. financial markets open. The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day. Conference Call Information Participants may access the conference call live via webcast on the ’Investors and Media’ page of Regeneron’s website at http ...

TARRYTOWN, N.Y., June 27, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that it will report its second quarter 2024 financial and operating results on Thursday, August 1, 2024, before the U.S. financial markets open. The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day. Conference Call Information Participants may access the conference call live via webcast on the ’Investors and Media’ page of Regeneron’s website at https ...

Majority of patients in this age group with eosinophilic esophagitis (EoE) receiving Dupixent achieved histologic remission, with improvements sustained up to one year Dupixent is the first and only treatment indicated for EoE in the U.S. for this age group TARRYTOWN, N.Y. and PARIS, June 26, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Sanofi today announced the New England Journal of Medicine (NEJM) has published results from a positive Phase 3 trial for Dupixent® (dupilumab) ...

Dupixent positive phase 3 data in children one to 11 years of age with eosinophilic esophagitis published in NEJM Majority of patients in this age group with eosinophilic esophagitis receiving Dupixent achieved histologic remission, with improvements sustained up to one yearDupixent is the first-and-only medicine indicated for eosinophilic esophagitis in the US for this age group Paris and Tarrytown, NY, June 26, 2024. The New England Journal of Medicine has published results from a positive phase 3 study o ...