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EMA接受Idefirix治疗急性髓性白血病和Xospata用于肾移植的上市授权申请

2019-03-04 不详 MedSci原创

欧洲药品管理局(EMA)已接受Hansa的Idefirix(imlifidase)和Astellas的Xospata(gilteritinib)的上市授权申请。 Xospata被批准用于治疗患有复发或难治性FLT3突变的急性髓性白血病(AML)的成人患者,而Idefirix则被批准用于应对高度敏感的肾移植患者体内的免疫反应。

欧洲药品管理局(EMA)已接受Hansa公司的Idefirix(imlifidase)和Astellas公司的Xospata(gilteritinib)的上市授权申请。

Xospata被批准用于治疗患有复发或难治性FLT3突变的急性髓性白血病(AML)的成人患者,而Idefirix则被批准用于应对高度敏感的肾移植患者体内的免疫反应。

接受Idefirix之后,Hansa于2019年2月5日提交了营销授权申请(MAA),标志着欧盟(EU)药物监管审查程序的开始,Xospata的申请是基于来自III期ADMIRAL试验:研究用于治疗成人FLT3突变的复发或难治性AML患者。

Hansa公司首席执行官表示:"MAA申请代表了Hansa的一个重要里程碑,因为它是我们的第一个上市许可监管申请,也是为等待肾脏移植的高度敏感患者提供Idefirix的重要一步。这些患者具有显着的未满足的医疗需求,经常在长期透析治疗中处于衰弱的疾病状态。"

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    2019-07-16 gostraight
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    2019-03-06 fengyi812
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    2019-03-06 bbjsj_1981
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