美国FDA延迟批准诺华的siRNA药物inclisiran

2020-12-19 Allan MedSci原创

高脂血症(Hyperlipidaemia)是指血液脂蛋白异常升高的情况。血脂的主要成分有胆固醇、三酸甘油酯与磷脂类。

高脂血症(Hyperlipidaemia)是指血液脂蛋白异常升高的情况。血脂的主要成分有胆固醇、三酸甘油酯与磷脂类。

诺华制药周五表示,FDA已就其inclisiran(一种针对PCSK9的siRNA药物)的市场营销申请发布了完整的回复函(CRL),该药物预计用于治疗LDL-胆固醇升高的成人高脂血症。这家瑞士制药商指出,FDA并未对inclisiran的功效或安全性提出任何担忧,但仍存在未解决的设施问题。

该药物于本月初在欧洲上市,用于治疗原发性高胆固醇血症或混合性血脂异常。该决定是基于ORION临床开发计划的结果,包括III期ORION-9研究、ORION-10研究和ORION-11研究,结果表明,inclisiran能够有效且持续地降低LDL-胆固醇(高达52%)。

诺华表示,将在10个工作日内将FDA提出的问题传达给欧洲制造工厂。

 

原始出处:

https://www.firstwordpharma.com/node/1785020?tsid=4

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    2020-12-27 chenxianglei

    从实验室走向临床运用,了不起的成就

    0

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