Authors:	Kayki-Mutlu, Gizem Aksoyalp, Zinnet Sevval Wojnowski, Leszek Michel, Martin C.
Title:	A year in pharmacology : new drugs approved by the US Food and Drug Administration in 2022
Online publication date:	27-Apr-2023
Year of first publication:	2023
Language:	english
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).
DDC:	610 Medizin 610 Medical sciences
Institution:	Johannes Gutenberg-Universität Mainz
Department:	FB 04 Medizin
Place:	Mainz
ROR:	https://ror.org/023b0x485
DOI:	http://doi.org/10.25358/openscience-9041
Version:	Published version
Publication type:	Zeitschriftenaufsatz
License:	CC BY
Information on rights of use:	https://creativecommons.org/licenses/by/4.0/
Journal:	Naunyn-Schmiedeberg's archives of pharmacology Version of Record (VoR)
Publisher:	Springer
Publisher place:	Berlin u.a.
Issue date:	2023
ISSN:	1432-1912
Publisher DOI:	10.1007/s00210-023-02465-x
Appears in collections:	DFG-491381577-H