美国食品和药物管理局审查Dupixent的新申请,用于治疗抗组胺药不反应的严重疹患者. FDA reviews new application for Dupixent to treat severe hives in those unresponsive to antihistamines.
美国食品和药物管理局已接受对Dupixent的补充生物药物许可申请 (sBLA) 的审查,该药物用于治疗不对抗组胺剂反应的12岁及以上的成年人和青少年的慢性自发性疹 (CSU). The FDA has accepted for review a supplemental biologics license application (sBLA) for Dupixent to treat chronic spontaneous urticaria (CSU) in adults and teens aged 12 and older who do not respond to antihistamines. 如果到2025年4月18日得到批准,Dupixent将是十年来CSU的第一个有针对性的疗法,为美国30多万受影响的人带来了希望。 If approved by April 18, 2025, Dupixent would be the first targeted therapy for CSU in a decade, offering hope to over 300,000 affected people in the US. 该应用程序有数据支持，表明 Dupixent 显着减少了瘙痒和荨麻疹活动。 The application is backed by data showing Dupixent significantly reduces itch and hive activity.