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2022年美国食品药品监督管理局潮汐项目(肽与寡核苷酸)成果

2022 FDA TIDES (Peptides and Oligonucleotides) Harvest.

作者信息

Al Musaimi Othman, Al Shaer Danah, Albericio Fernando, de la Torre Beatriz G

机构信息

Department of Chemical Engineering, Imperial College London, London SW7 2AZ, UK.

Department of Medicinal Chemistry, Evotec (UK) Ltd., Abingdon OX14 4R, UK.

出版信息

Pharmaceuticals (Basel). 2023 Feb 22;16(3):336. doi: 10.3390/ph16030336.

Abstract

A total of 37 new drug entities were approved in 2022; although that year registered the lowest number of drug approvals since 2016, the TIDES class consolidated its presence with a total of five authorizations (four peptides and one oligonucleotide). Interestingly, 23 out of 37 drugs were first-in-class and thus received fast-track designation by the FDA in categories such as breakthrough therapy, priority review voucher, orphan drug, accelerated approval, and so on. Here, we analyze the TIDES approved in 2022 on the basis of their chemical structure, medical target, mode of action, administration route, and common adverse effects.

摘要

2022年共批准了37种新的药物实体;尽管该年的药物批准数量是2016年以来最少的,但TIDES类别仍以总计五项授权(四种肽类和一种寡核苷酸)巩固了其地位。有趣的是,37种药物中有23种是同类首创药物,因此在诸如突破性疗法、优先审评券、孤儿药、加速批准等类别中获得了美国食品药品监督管理局(FDA)的快速通道指定。在此,我们根据2022年批准的TIDES药物的化学结构、医学靶点、作用方式、给药途径和常见不良反应进行分析。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/afa0/10056021/4fb5939f80df/pharmaceuticals-16-00336-g001.jpg

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