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
在优先审评后，Dupixent现已适用于12岁及以上，控制不佳的鼻窦炎伴鼻息肉患者。
Current treatment options leave many patients with uncontrolled disease and often result in the recurrence of nasal polyps
现有的治疗选择使许多患者疾病无法控制，并且往往导致鼻息肉的复发。
Dupixent is the leading biologic medicine for all five FDA-approved indications in new-to-brand prescriptions
Dupixent是所有五个FDA批准的适应症中领先的生物制剂药物，用于新处方品牌。
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.
纽约TARRYTOWN和巴黎，2024年9月13日（环球新闻社） - 再生元制药公司（纳斯达克：REGN）和赛诺菲今天宣布，美国食品药品监督管理局（FDA）已批准Dupixent（dupilumab）作为辅助维持治疗，用于12至17岁的青少年患者，其慢性鼻窦炎伴鼻息肉（CRSwNP）控制不佳。此次批准扩大了2019年6月FDA针对18岁及以上患者的CRSwNP批准。FDA在优先审评下评估了Dupixent的这一扩展适应症，优先审评针对的是那些在治疗严重疾病中具有潜在显著疗效或安全性改进的药物。
