智通财经APP获悉，再生元(REGN.US)和赛诺菲(SNY.US)联合开发的重磅疗法Dupixent(dupilumab)获美国FDA批准，用于治疗大疱性类天疱疮(BP)成人患者。根据新闻稿，Dupixent是获美国FDA批准的首款BP疗法。
据悉，BP是一种慢性且易复发的皮肤病，伴有潜在的2型炎症，通常发生于老年人群。其特点为剧烈瘙痒、水疱、皮肤发红及疼痛性病变。水疱和皮疹可能遍布全身，导致皮肤出血和结痂，使患者更易感染，并影响日常生活。
分析结果显示，在主要终点上，18.3%的患者实现了持续疾病缓解，而安慰剂组为6.1%(差值12.2%；95% CI：-0.8%至26.1%)。另外，38.3%的患者实现了临床意义上的瘙痒缓解，此数值在安慰剂组为10.5%。此外，Dupixent组患者的口服皮质类固醇累计中位剂量为2.8克，低于安慰剂组的4.1克。
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