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 2021
Online publication date:	5-Jan-2023
Year of first publication:	2022
Language:	english
Abstract:	The second year of the COVID-19 pandemic had no adverse effect on the number of new drug approvals by the US Food and Drug Administration (FDA). Quite the contrary, with a total of 50 new drugs, 2021 belongs to the most successful FDA years. We assign these new drugs to one of three levels of innovation: (1) first drug against a condition (“first-in-indication”), (2) first drug using a novel molecular mechanism (“first-in-class”), and (3) “next-in-class”, i.e., a drug using an already exploited molecular mechanism. We identify 21 first-in-class, 28 next-in-class, and only one first-in-indication drugs. By treatment area, the largest group is once again cancer drugs, many of which target specific genetic alterations. Every second drug approved in 2021 targets an orphan disease, half of them being cancers. Small molecules continue to dominate new drug approvals, followed by antibodies and non-antibody biopharmaceuticals. In 2021, the FDA continued to approve drugs without strong evidence of clinical effects, best exemplified by the aducanumab controversy.
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-8337
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 395
Pages or article number:	867 885
Publisher:	Springer
Publisher place:	Berlin u.a.
Issue date:	2022
ISSN:	1432-1912
Publisher DOI:	10.1007/s00210-022-02250-2
Appears in collections:	DFG-491381577-H