**款针对高风险流感并发症药物Xofluza,喜获FDA批准

2019-10-19 不详 MedSci原创m

Genentech的Xofluza(baloxavir marboxil)已获得美国食品和药物管理局(FDA)的补充新药申请(NDA)批准,用于症状出现不超过48小时且严重流感并发症高风险的12岁及以上的急性流感人群。

Genentech的Xofluza(baloxavir marboxil)已获得美国食品和药物管理局(FDA)的补充新药申请(NDA)批准,用于症状出现不超过48小时且严重流感并发症高风险的12岁及以上的急性流感人群。

此次批准标志着该药物是第一种也是唯一的一种专门针对有高风险发展为流感严重并发症风险的患者的抗病毒药物。该药物批准是根据CAPSTONE-2 III期研究的结果,该研究人群为12岁以上符合CDC的流感并发症高风险标准。

根据疾病控制与预防(CDC)中心定义的患有严重流感并发症的高风险人群,包括哮喘、慢性肺病、糖尿病、心脏病、病态肥胖或65岁以上的成年人等,将从该药物的治疗中受益。

Xofluza目前已在多个国家获得批准用于治疗A型和B型流感。

原始出处:


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    2020-09-13 丁鹏鹏
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    2020-07-26 bugit
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