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FDA将瑞德西韦的紧急使用授权扩大到所有COVID-19住院患者

2020-08-31 Allan MedSci原创

瑞德西韦Covid-19紧急使用授权（EUA）
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FDA扩大了吉利德科学公司Veklury（瑞德西韦）的现有紧急使用授权（EUA）的范围，以对所有怀疑或实验室确认的COVID-19住院患者进行治疗，且无论其疾病严重程度如何。III期ACTT试验的初步

FDA扩大了吉利德科学公司Veklury（瑞德西韦）的现有紧急使用授权（EUA）的范围，以对所有怀疑或实验室确认的COVID-19住院患者进行治疗，且无论其疾病严重程度如何。III期ACTT试验的初步结果表明，瑞德西韦组患者的平均恢复时间缩短了四天，瑞德西韦于5月获得了FDA的批准，可用于重症COVID-19患者。

吉利德首席医学官Merdad Parsey评论说：“扩大后的授权使医生能够更广泛地使用瑞德西韦。随着我们对COVID-19的了解越来越多，我们进一步确认了Veklury的功效和安全性”。

除ACTT试验外，另一项名为SIMPLE的研究发现，接受Veklury五天疗程加标准护理的中度COVID-19肺炎患者在第11天获得显著的临床改善。但是，10天疗程改善的几率与标准护理无明显差异。SIMPLE研究结果最近发表在《JAMA》上。

FDA的结论是，Veklury的已知和潜在利益超过了潜在风险，FDA有理由相信Veklury可以对所有COVID-19住院患者有效。

 

原始出处：

https://www.firstwordpharma.com/node/1753287?tsid=4

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    2020-09-02 14818eb4m67暂无昵称

    学习

    0

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    2020-09-02 guguangxiang

    #紧急#

    0

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    2020-09-01 14818eb4m67暂无昵称

    学习

    0

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    2020-08-31 Psycho.Dr Du

    jama不是说对中度COVID-19没有明显疗效吗#新冠肺炎#🤔

    0

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    2020-08-31 Baodongxu

    如何改善支持治疗质量也应该是研究方向

    0

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