欧洲药品管理局接受葛兰素史克的申请,寻求将Trelegy Ellipta三联吸入式疗法用于治疗哮喘

2020-03-02 不详 MedSci原创

欧洲药品管理局(EMA)已接受葛兰素史克(GlaxoSmithKline)的监管申请,寻求增加Trelegy Ellipta(fluticasone furoate/umeclidinium/vilanterol)的适应症。

欧洲药品管理局(EMA)已接受葛兰素史克(GlaxoSmithKline)的监管申请,寻求增加Trelegy Ellipta(fluticasone furoate/umeclidinium/vilanterol)的适应症。

该申请基于III期临床CAPTAIN研究的结果,Trelegy是一种每日一次、单次吸入的三联疗法。两家公司证实,该研究达到了其主要终点,与ICS / LABA,Relvar / Breo Ellipta相比,肺功能具有统计学上的显着改善。

就目前而言,在欧洲尚无单一的吸入式三联疗法可用于治疗哮喘,而且即使坚持ICS / LABA治疗,至少有30%的哮喘患者仍会继续出现症状。

去年10月,葛兰素史克(GSK)还向美国食品和药物管理局(FDA)提交了补充新药申请(sNDA),以寻求相同的适应症扩展。

自2017年11月以来,该药物已在欧盟批准用于治疗慢性阻塞性肺病(COPD)患者,这些患者无法通过ICS/LABA或LABA和长效毒蕈碱拮抗剂的组合得到充分治疗。

原始出处:


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