赛诺菲(SNY)美国FDA已批准Dupixent用于治疗成人大疱性类天疱疮

金吾财讯
20 Jun

金吾财讯 | 赛诺菲(SNY)周五表示,美国食品和药物管理局(FDA)已批准Dupixent(又名 dupilumab),用于治疗成人大疱性类天疱疮(BP)患者,这是一种罕见的慢性皮肤病。

此次批准基于2/3期Adept研究的数据,该研究评估了Dupixent与安慰剂相比的疗效和安全性。研究中,18.3%的患者获得了持续的疾病缓解,38.3%的患者获得了临床意义上的瘙痒减轻,而安慰剂组分别为6.1%和10.5%。这家法国生物制药公司还向其他市场申请了Dupixent的监管批准,包括欧盟、日本和中国。

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