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。
PBC作为一种胆汁淤积性肝病,会导致肝脏胆汁流动受阻。由此引发的循环胆汁酸过量被认为是胆汁淤积性瘙痒症(一种无法通过抓挠缓解的内源性瘙痒)的致病因素。该瘙痒可发生于PBC疾病或生化控制的任何阶段,严重程度各异,约90%的PBC患者会出现此症状。虽然PBC一线治疗可控制约70%患者的病情,但无法减轻瘙痒的严重程度或影响。胆汁淤积性瘙痒症是一种可能致残的严重病症,患者会出现睡眠障碍、疲劳、生活质量下降,甚至可能在未出现肝功能衰竭的情况下需进行肝移植。
Linerixibat是一种IBAT口服抑制剂,具有治疗与PBC相关的胆汁淤积性瘙痒的潜力。通过抑制胆汁酸重吸收,linerixibat可减少循环中多种瘙痒介质
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