Please use this identifier to cite or link to this item:
http://doi.org/10.25358/openscience-8337
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 |
Files in This Item:
File | Description | Size | Format | ||
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a_year_in_pharmacology__new_d-20221117155652490.pdf | 1.04 MB | Adobe PDF | View/Open |