Eli Lilly Requests FDA Revoke EUA For Bamlanivimab 700 Mg Alone - Quick Facts

礼来要求FDA撤销单用700毫克班兰尼单抗的EUA-快速事实

2021-04-16 21:00:12 RTTNews

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Eli Lilly and Company (LLY) has requested the FDA revoke the Emergency Use Authorization for bamlanivimab 700 mg alone. This is the final step in the company's transition to only supply bamlanivimab and etesevimab for administration together in the U.S. for the treatment of COVID-19. The company noted that the request is not due to any new safety concern. Lilly's bamlanivimab was the first neutralizing monoclonal antibody to receive emergency use authorization from the FDA as a treatment for mild to moderate COVID-19. Lilly said all sites in the U.S. now have access to obtain doses of etesevimab for administration with bamlanivimab — which together neutralize more of the emerging COVID-19 variants in the U.S. than bamlanivimab alone. Lilly, in collaboration with Amgen, plans to manufacture sufficient supply of bamlanivimab and etesevimab together. Lilly will submit only bamlanivimab administered with etesevimab together for authorization globally with a full transition expected by June 2021. For comments and feedback contact: editorial@rttnews.com Business News
礼来公司(LLY)已要求FDA撤销单独使用700毫克班兰尼单抗的紧急使用授权。这是该公司向在美国仅供应用于治疗COVID-19的bamlanivimab和etesevimab联合给药过渡的最后一步。该公司指出,这一要求并不是出于任何新的安全考虑。 礼来的bamlanivimab是第一个获得FDA紧急使用授权的中和单克隆抗体,用于轻中度新冠肺炎的治疗。礼来表示,美国的所有站点现在都可以获得乙塞维单抗的剂量,用于与巴姆拉尼单抗一起使用--两者联合使用比单独使用巴姆拉尼单抗能够中和更多美国新出现的COVID-19变体。 礼来与安进合作,计划一起制造足够供应的bamlanivimab和etesevimab。礼来将只提交bamlanivimab与etesevimab联合使用的全球授权,预计2021年6月前全面过渡。 如需评论和反馈,请联系:editorial@rttnews.com 商业新闻

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