诺华宣布其联合疗法QVM149和QMF149针对不受控的哮喘病患者III期阳性结果

2019-10-06 不详 MedSci原创

​诺华宣布,在不受控制的哮喘中,其联合疗法QVM149(醋酸茚达特罗/溴化吡格隆溴铵/糠酸莫米松)和QMF149(醋酸茚达特罗/糠酸莫米松)联合疗法在III期均喜获阳性结果。

诺华宣布,在不受控制的哮喘中,其联合疗法QVM149(醋酸茚达特罗/溴化吡格隆溴铵/糠酸莫米松)和QMF149(醋酸茚达特罗/糠酸莫米松)在III期均喜获阳性结果。


该公司宣布,两项III期研究显示出肺功能有明显改善,达到了该试验的主要终点。它还提醒人们,通过Breezhaler设备每天服用一次的QVM149和QMF149营销申请,目前正在由欧洲药品管理局进行审查。


IRIDIUM是第一个用于评估高剂量QVM149和QMF149相对于GlaxoSmithKline的每天两次Advair(沙美特罗/氟替卡松)疗效的试验。该试验包括约3092名中高剂量长效β受体激动剂(LABA)和吸入皮质类固醇(ICS)联合使用但未控制哮喘的患者,并且发现26周后,QVM149在改善一秒钟内低谷强迫呼气量(FEV1)方面优于QMF149。


诺华制药公司呼吸发展部门负责人琳达·阿姆斯特朗(Linda Armstrong)说:"这些初步的IRIDIUM阳性结果与今年早些时候在ATS上公布的II期结果相符,并加强了证据表明,如果获批,中、高剂量QVM149可能对接受中高剂量LABA / ICS治疗后仍无法控制的哮喘患者有益。"


原始出处:


http://www.pharmatimes.com/news/novartis_announces_positive_asthma_results_1311623


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    2020-08-02 juliusluan78
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    2019-12-24 晓辰
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