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Review
. 2023 Aug;396(8):1619-1632.
doi: 10.1007/s00210-023-02465-x. Epub 2023 Mar 23.

A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2022

Gizem Kayki-Mutlu #  1 , Zinnet Sevval Aksoyalp #  2 , Leszek Wojnowski  3 , Martin C Michel  4
Affiliations
Review

A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2022

Gizem Kayki-Mutlu et al. Naunyn Schmiedebergs Arch Pharmacol. 2023 Aug.

Abstract

While new drug approvals by the U.S. Food and Drug Administration (FDA) had remained stable or even increased in the first 2 years of the COVID-19 pandemic, the 37 newly approved drugs in 2022 are considerably less than the 53 and 50 new drugs approved in 2020 and 2021, respectively, and less than the rolling 10-year average of 43. As in previous years of this annual review, we assign these new drugs to one of three levels of innovation: first drug against a condition ("first-in-indication"), first drug using a novel molecular mechanism ("first-in-class"), and "next-in-class," i.e., a drug using an already exploited molecular mechanism. We identify two "first-in-indication" (ganaxolon and teplizumab), 20 (54%) "first-in-class," and 17 (46%) "next-in-class" drugs. By treatment area, rare diseases and cancer drugs were once again the most prevalent (partly overlapping) therapeutic areas. Other continuing trends were the use of accelerated regulatory approval pathways and the reliance on biopharmaceuticals (biologics).

Keywords: FDA; First-in-class; New drugs; Next-in-class.

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Conflict of interest statement

GKM, ZSA and LW do not report a conflict of interest. MCM is a consultant and/or lecturer to Apogepha, Astellas, Dr. Willmar Schwabe, GSK, and Sanofi-Aventis.

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