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
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. 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適用於美國約30萬名患有控制不當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
在歐盟和中國最近的批准之後，美國的批准基於兩項具有里程碑意義的3期臨床試驗證明Dupixent在減少惡化方面取得了顯著效果，並且在肺功能和健康相關生活質量方面與安慰劑相比也有所改善。
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批准的所有適應症中領先的生物製劑藥物，在新品牌處方中排名第一，並且是美國肺病學家處方最多的生物製劑藥物。
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.
紐約州塔裏敦和巴黎，2024年9月27日（環球新聞社） - 再生元製藥公司（NASDAQ：REGN）和賽諾菲安萬特今天宣佈，美國食品和藥物管理局（FDA）已批准Dupixent（度匹單抗）作爲成年患有控制不當的慢性阻塞性肺疾病（COPD）和嗜酸性表型的患者的附加維持治療。Dupixent是美國批准用於治療這些患者的第一種生物製劑藥物。
譯文內容由第三人軟體翻譯。