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2020年回顾:美国食品药品监督管理局(FDA)批准的新药

2020 in review: FDA approvals of new medicines.

作者信息

Kinch Michael S, Kraft Zachary, Schwartz Tyler

机构信息

Center for Research Innovation and Biotechnology, Washington University in St. Louis, St. Louis, MO 63130, USA.

Center for Research Innovation and Biotechnology, Washington University in St. Louis, St. Louis, MO 63130, USA.

出版信息

Drug Discov Today. 2021 Dec;26(12):2794-2799. doi: 10.1016/j.drudis.2021.07.003. Epub 2021 Jul 10.

Abstract

Amid a global pandemic, the US Food and Drug Administration (FDA) remained relatively active, approving 55novel molecular entities (NMEs) in 2020, the third highest annual rate recorded. Orphan approvals also surged, capturing 60% of NMEs introduced during 2020, as did the number of NMEs approved using a priority review. The pandemic did appear to impact one recent trend, and in a paradoxically encouraging way. Escalating rates of consolidation slowed in 2020, with only 102 companies lost, down by two-thirds over the rate in 2019. This leaves 2000 extant clinical-stage pharmaceutical companies. When limiting this analysis to companies contributing to the research and development (R&D) of an approved drug, eight were lost, leaving 144 extant.

摘要

在全球大流行期间,美国食品药品监督管理局(FDA)依然相当活跃,2020年批准了55种新型分子实体(NME),这是有记录以来的第三高年度批准率。孤儿药的批准数量也大幅增加,占2020年引入的NME的60%,使用优先审评批准的NME数量亦是如此。大流行似乎确实影响了一个近期趋势,而且是以一种矛盾但令人鼓舞的方式。2020年合并率的上升有所放缓,仅有102家公司消失,比2019年的速度下降了三分之二。这使得现存2000家临床阶段的制药公司。若将此分析限定于为已批准药物的研发做出贡献的公司,有8家公司消失,现存144家。

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