Regeneron Pharmaceuticals And Sanofi Announce FDA Approval For Dupixent In The U.S. As First And Only Treatment For Adolescents With Chronic Rhinosinusitis With Nasal Polyps
Regeneron Pharmaceuticals And Sanofi Announce FDA Approval For Dupixent In The U.S. As First And Only Treatment For Adolescents With Chronic Rhinosinusitis With Nasal Polyps
TARRYTOWN, N.Y. and PARIS, Sept. 13, 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 for adolescent patients aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). This approval expands the initial June 2019 FDA approval in CRSwNP for patients aged 18 years and older. The FDA evaluated Dupixent for this expanded indication under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions.Following Priority Review, Dupixent is now available to patients as young as 12 years with inadequately controlled CRSwNP
在優先審評後，Dupixent現已適用於12歲及以上，控制不佳的鼻竇炎伴鼻息肉患者。
Current treatment options leave many patients with uncontrolled disease and often result in the recurrence of nasal polyps
現有的治療選擇使許多患者疾病無法控制，並且往往導致鼻息肉的復發。
Dupixent is the leading biologic medicine for all five FDA-approved indications in new-to-brand prescriptions
Dupixent是所有五個FDA批准的適應症中領先的生物製劑藥物，用於新處方品牌。
TARRYTOWN, N.Y. and PARIS, Sept. 13, 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 for adolescent patients aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). This approval expands the initial June 2019 FDA approval in CRSwNP for patients aged 18 years and older. The FDA evaluated Dupixent for this expanded indication under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions.
紐約TARRYTOWN和巴黎，2024年9月13日（環球新聞社） - 再生元製藥公司（納斯達克：REGN）和賽諾菲今天宣佈，美國食品藥品監督管理局（FDA）已批准Dupixent（dupilumab）作爲輔助維持治療，用於12至17歲的青少年患者，其慢性鼻竇炎伴鼻息肉（CRSwNP）控制不佳。此次批准擴大了2019年6月FDA針對18歲及以上患者的CRSwNP批准。FDA在優先審評下評估了Dupixent的這一擴展適應症，優先審評針對的是那些在治療嚴重疾病中具有潛在顯著療效或安全性改進的藥物。
