再生元(REGN.US)和赛诺菲(SNY.US)重磅抗炎药年中有望再添新适应症

智通财经03-11

智通财经APP获悉，日前，再生元(REGN.US)和赛诺菲(SNY.US)在2025年美国皮肤科学会(AAD)年会上，公布了关键性2/3期临床试验ADEPT的积极结果。该试验评估重磅疗法Dupixent(dupilumab)在治疗中重度大疱性类天疱疮(BP)成人患者时的疗效和安全性。ADEPT试验达到了所有主要及关键次要终点，接受Dupixent治疗的患者获得持久缓解的比例是安慰剂组的5倍。Dupixent治疗BP的补充生物制品许可申请(sBLA)已经获得FDA授予的优先审评资格，有望在今年年中获批。

Dupixent是一种全人源化单克隆抗体，能够抑制白细胞介素4(IL-4)和白细胞介素13(IL-13)信号通路。它已在全球60多个国家和地区获得一种或多种适应症的监管批准，包括特应性皮炎、哮喘、伴鼻息肉的慢性鼻窦炎、嗜酸性食管炎、结节性瘙痒症、慢性自发性荨麻疹及慢性阻塞性肺病。全球有超过100万名患者正在接受Dupixent治疗。

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