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FDA评估alirocumab神经认知副作用

2014-03-26 伊文 中国医学论坛报手机报

美国食品与药物管理局(FDA)日前要求研发降脂药物alirocumab的合作伙伴——赛诺菲和再生元(Regeneron)制药公司监测应用alirocumab患者可能的神经认知不良事件。两家公司均表示,他们并不知悉应用alirocumab与不良神经认知预后有关。alirocumab为针对前蛋白转化酶枯草溶菌素9(proprotein convertase subtilisin/kexin type

美国食品与药物管理局(FDA)日前要求研发降脂药物alirocumab的合作伙伴——赛诺菲和再生元(Regeneron)制药公司监测应用alirocumab患者可能的神经认知不良事件。

两家公司均表示,他们并不知悉应用alirocumab与不良神经认知预后有关。alirocumab为针对前蛋白转化酶枯草溶菌素9(proprotein convertase subtilisin/kexin type 9,PCSK9)的人单克隆抗体,此类单克隆抗体目前是研究热门,数个制药公司正在研发产品,如辉瑞的bococizumab和安进的evolocumab正处于研发的不同阶段。




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    2014-09-26 linlin2312
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    2014-06-25 snf701207
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