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重磅:吉利德乙肝药物Vemlidy获欧盟批准进入欧洲市场

2017-01-17 佚名 生物谷

据悉,欧洲委员会已经授权吉利德的药物Vemlidy进入欧洲市场,这标志着欧盟近十年来首个乙肝病毒(HBV)疗法获批。 经过对主席11月批准建议的确认,欧盟点头授权吉利德乙肝药物进入欧洲市场,可在欧盟28个成员国以及挪威和冰岛进行成年人及青少年HBV感染的治疗。 早在2016年年末,该药物就已经获得美国FDA批准用于治疗成年人HBV感染及控制肝病,同时也获得日本卫生、劳动和福利部门的批准。


据悉,欧洲委员会已经授权吉利德的药物Vemlidy进入欧洲市场,这标志着欧盟近十年来首个乙肝病毒(HBV)疗法获批。

经过对主席11月批准建议的确认,欧盟点头授权吉利德乙肝药物进入欧洲市场,可在欧盟28个成员国以及挪威和冰岛进行成年人及青少年HBV感染的治疗。

早在2016年年末,该药物就已经获得美国FDA批准用于治疗成年人HBV感染及控制肝病,同时也获得日本卫生、劳动和福利部门的批准。

Vemlidy(替诺福韦艾拉酚胺,TAF)是一个每日一次的口服药物,可以产生其前身Viread(富马酸替诺福韦酯,TDF)相同的效果,但是剂量减小到了原来的十分之一。由于替诺福韦的剂量减少,TAF治疗降低了对肾脏及骨的副作用。

吉利德的执行副总裁和首席科学家Norbert Bischofberger博士说道:“TAF反映了吉利德改善和简化包括HBV在内的慢性感染疾病治疗的决心,同时我们还在不断努力提高治疗药物的疗效。我们期待TAF尽快在欧盟使用。”

HBV是癌症的第二大诱因,据乙型肝炎基金会介绍,全球有2.4亿人感染HBV,每年会引起680000人死亡。

WHO 2016年的报告显示欧洲有1300万HBV携带者,每年有100万新发感染者。

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    2017-10-20 howi
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    2017-01-19 xxxx1054
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