美國FDA:衞材和百健的阿爾茨海默病藥物後期數據積極
格隆匯6月8日丨美國FDA工作人員週三表示,衞材和百健(BIIB.US)的阿爾茨海默病藥物Leqembi的後期試驗數據表明,該藥為患者提供了的益處,安全問題可能不會妨礙其獲得傳統批准的機會。在週五的外部顧問小組會議之前發佈的文件中,FDA工作人員沒有強調與該藥物Leqembi有關的任何新風險,該小組將討論這些公司的全面批准申請。分析師們説,這些文件似乎暗示該藥物獲得批准。美國食品和藥物管理局的決定預計將在7月6日作出決定。RBC資本市場的分析師Brian Abrahams認為該藥年銷售額最終會達到100億美元。衞材申請全面批准的依據是,數據顯示Leqembi與安慰劑相比,將早期阿爾茨海默病患者的認知能力下降速度減緩了27%。
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