Drug Discovery Today ( IF 7.4 ) Pub Date : 2020-09-11 , DOI: 10.1016/j.drudis.2020.09.002 Michael S Kinch 1 , Zachary Kraft 1 , Tyler Schwartz 1
The US Food and Drug Administration (FDA) green-lighted the marketing of 53 therapeutic agents in 2019. This rate of approvals was consistent with the 5-year running average. Nonetheless, a few changes are worth noting. The rate of medicines first approved using an orphan drug designation declined from 56% in 2018 to 41% in 2019, which mirrored a comparable decline in the use of priority review. A second notable feature was an uptick in industry consolidation. Twenty-five companies were lost, primarily because of mergers, leaving only 146 extant companies that have contributed to the research or development of an innovative FDA-approved medicine.
中文翻译:
2019年回顾:FDA批准了新药。
美国食品药品监督管理局(FDA)在2019年为53种治疗剂的营销开了绿灯。批准率与5年运行平均值一致。尽管如此,仍需要注意一些更改。首次批准使用孤儿药名称的药物比率从2018年的56%下降到2019年的41%,这反映出优先审查的使用率出现了类似的下降。第二个显着特征是行业整合的增加。有25家公司倒闭,主要是由于合并造成的损失,仅留下了146家为FDA批准的创新药物的研究或开发做出贡献的现有公司。