智通财经APP获悉,12月10日,中国国家药监局药品审评中心(CDE)官网公示,艾伯维(ABBV.US)申报的乌帕替尼缓释片拟纳入优先审评,拟定适应症为治疗成人巨细胞动脉炎(GCA)。乌帕替尼缓释片(upadacitinib)是一种JAK抑制剂,此前已在中国获批治疗多种其它适应症。今年7月,艾伯维已经完成向美国FDA和欧洲药品管理局(EMA)提交该产品用于治疗成年巨细胞动脉炎(GCA)患者的新适应症申请。
GCA是一种自身免疫性疾病,导致颞动脉和其他颅内动脉、主动脉以及其他大中型动脉的炎症。GCA通常影响50岁以上的老年患者,最常见的年龄段在70至80岁之间。女性患此病的风险最高,症状可能包括头痛、下颌痛以及视力变化或丧失,可能出现突然和永久的视力丧失。
艾伯维此前新闻稿介绍,GCA是一种主要影响老年人的大动脉炎症疾病,迄今为止只获批了一种治疗方法,通常与激素一起使用。根据研究结果,乌帕替尼缓释片有可能成为GCA患者的第一个口服治疗药物选择。
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