美国FDA推迟审批再生元(REGN.US)/赛诺菲(SNY.US)Dupixent用于治疗COPD

智通财经网05-31

智通财经APP获悉，再生元制药公司(REGN.US)和赛诺菲(SNY.US)周五宣布，美国FDA推迟对其重磅药物Dupixent (dupilumab)用于治疗慢性阻塞性肺疾病(COPD)的决定。今年2月，再生元和赛诺菲宣布，FDA已接受Dupixent的补充生物制品许可申请(sBLA)，并授予优先审评资格。此次的适应症为：用于患有病情不受控制的COPD成年患者的附加维持治疗。目标行动日期定在...

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