再生元(REGN)与赛诺菲(SNY)抗炎药年中或迎新适应症获批

金吾财讯03-11

金吾财讯 | 再生元(REGN)与赛诺菲(SNY)在2025年美国皮肤科学会年会上公布，其IL-4/IL-13抑制剂Dupixent(达必妥)治疗中重度大疱性类天疱疮(BP)的2/3期ADEPT试验达到全部主要及关键次要终点：治疗组持续缓解率是安慰剂组的5倍。FDA已受理该适应症补充申请并授予优先审评，预计2025年年中获批。Dupixent作为全球首个获批的IL-4/IL-13双通路抑制剂，已在7大适应症(特应性皮炎、哮喘等)覆盖60多个国家，惠及超百万患者。此次新适应症针对自身免疫性大疱病，其独特的"靶向抑制+免疫调节"机制为传统疗法耐药患者提供新选择。

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