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Regeneron Pharmaceuticals Announces Dupixent Approved In The U.S. As The First-Ever Biologic Medicine For Patients With COPD

Regeneron Pharmaceuticals Announces Dupixent Approved In The U.S. As The First-Ever Biologic Medicine For Patients With COPD

再生元制药公司宣布杜必信在美国获得批准,成为首个用于慢性阻塞性肺病患者的生物制药。
Benzinga ·  09/27 09:36

Dupixent is indicated for the approximately 300,000 adults in the U.S. with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype

Dupixent适用于美国约30万名患有控制不当的慢性阻塞性肺疾病(COPD)和嗜酸性表型的成年人。

Following recent approvals in the EU and China, the U.S. approval is based on two landmark Phase 3 trials that showed Dupixent achieved significant reduction in exacerbations, and also showed improvements in lung function and health-related quality of life compared to placebo

在欧盟和中国最近的批准之后,美国的批准基于两项具有里程碑意义的3期临床试验证明Dupixent在减少恶化方面取得了显著效果,并且在肺功能和健康相关生活质量方面与安慰剂相比也有所改善。

Dupixent is the leading biologic medicine for all of its FDA-approved indications in new-to-brand prescriptions, and the most prescribed biologic by pulmonologists in the U.S.

Dupixent是FDA批准的所有适应症中领先的生物制剂药物,在新品牌处方中排名第一,并且是美国肺病学家处方最多的生物制剂药物。

TARRYTOWN, N.Y. and PARIS, Sept. 27, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) as an add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. Dupixent is the first biologic medicine approved in the U.S. to treat these patients.

纽约州塔里敦和巴黎,2024年9月27日(环球新闻社) - 再生元制药公司(NASDAQ:REGN)和赛诺菲安万特今天宣布,美国食品和药物管理局(FDA)已批准Dupixent(度匹单抗)作为成年患有控制不当的慢性阻塞性肺疾病(COPD)和嗜酸性表型的患者的附加维持治疗。Dupixent是美国批准用于治疗这些患者的第一种生物制剂药物。

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