【葛兰素史克(GSK.US)口服靶向新药“利奈昔巴特片”在中国拟纳入优先审评】智通财经APP获悉,7月4日,中国国家药监

智通财经
04 Jul
【葛兰素史克(GSK.US)口服靶向新药“利奈昔巴特片”在中国拟纳入优先审评】智通财经APP获悉,7月4日,中国国家药监局药品审评中心(CDE)官网公示,葛兰素史克(GSK.US)申报的利奈昔巴特片拟纳入优先审评,适用于治疗原发性胆汁性胆管炎(PBC)成人患者的胆汁淤积性瘙痒。公开资料显示,这是GSK在研的回肠胆汁酸转运蛋白(IBAT)抑制剂linerixibat。该产品的新药申请(NDA)已经于今年6月获美国FDA及欧洲药品管理局(EMA)受理,适应症为治疗原发性胆汁性胆管炎(PBC)成人患者的胆汁淤积性瘙痒。

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