Gutenberg Open Science: A year in pharmacology : new drugs approved by the US Food and Drug Administration in 2021

Please use this identifier to cite or link to this item: http://doi.org/10.25358/openscience-8337

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DC Field	Value	Language
dc.contributor.author	Kayki-Mutlu, Gizem	-
dc.contributor.author	Aksoyalp, Zinnet Sevval	-
dc.contributor.author	Wojnowski, Leszek	-
dc.contributor.author	Michel, Martin C.	-
dc.date.accessioned	2023-01-05T08:57:54Z	-
dc.date.available	2023-01-05T08:57:54Z	-
dc.date.issued	2022	-
dc.identifier.uri	https://openscience.ub.uni-mainz.de/handle/20.500.12030/8353	-
dc.description.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.	en_GB
dc.description.sponsorship	Gefördert durch die Deutsche Forschungsgemeinschaft (DFG) - Projektnummer 491381577	de
dc.language.iso	eng	de
dc.rights	CC BY	*
dc.rights.uri	https://creativecommons.org/licenses/by/4.0/	*
dc.subject.ddc	610 Medizin	de_DE
dc.subject.ddc	610 Medical sciences	en_GB
dc.title	A year in pharmacology : new drugs approved by the US Food and Drug Administration in 2021	en_GB
dc.type	Zeitschriftenaufsatz	de
dc.identifier.doi	http://doi.org/10.25358/openscience-8337	-
jgu.type.dinitype	article	en_GB
jgu.type.version	Published version	de
jgu.type.resource	Text	de
jgu.organisation.department	FB 04 Medizin	de
jgu.organisation.number	2700	-
jgu.organisation.name	Johannes Gutenberg-Universität Mainz	-
jgu.rights.accessrights	openAccess	-
jgu.journal.title	Naunyn-Schmiedeberg's archives of pharmacology	de
jgu.journal.volume	395	de
jgu.pages.start	867	de
jgu.pages.end	885	de
jgu.publisher.year	2022	-
jgu.publisher.name	Springer	de
jgu.publisher.place	Berlin u.a.	de
jgu.publisher.issn	1432-1912	de
jgu.organisation.place	Mainz	-
jgu.subject.ddccode	610	de
jgu.publisher.doi	10.1007/s00210-022-02250-2	de
jgu.organisation.ror	https://ror.org/023b0x485	-
jgu.subject.dfg	Lebenswissenschaften	de
Appears in collections:	DFG-491381577-H

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