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A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2020

While the COVID-19 pandemic also affected the work of regulatory authorities, the US Food and Drug Administration approved a total of 53 new drugs in 2020, one of the highest numbers in the past decades. Most newly approved drugs related to oncology (34%) and neurology (15%). We discuss these new dr...

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Autores principales: Kayki-Mutlu, Gizem, Michel, Martin C.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8051285/
https://www.ncbi.nlm.nih.gov/pubmed/33864098
http://dx.doi.org/10.1007/s00210-021-02085-3
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author Kayki-Mutlu, Gizem
Michel, Martin C.
author_facet Kayki-Mutlu, Gizem
Michel, Martin C.
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description While the COVID-19 pandemic also affected the work of regulatory authorities, the US Food and Drug Administration approved a total of 53 new drugs in 2020, one of the highest numbers in the past decades. Most newly approved drugs related to oncology (34%) and neurology (15%). We discuss these new drugs by level of innovation they provide, i.e., first to treat a condition, first using a novel mechanisms of action, and “others.” Six drugs were first in indication, 15 first using a novel mechanism of action, and 32 other. This includes many drugs for the treatment of orphan indications and some for the treatment of tropical diseases previously neglected for commercial reasons. Small molecules continue to dominate new drug approvals, followed by antibodies. Of note, newly approved drugs also included small-interfering RNAs and antisense oligonucleotides. These data show that the trend for declines in drug discovery and development has clearly been broken.
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spelling pubmed-80512852021-04-16 A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2020 Kayki-Mutlu, Gizem Michel, Martin C. Naunyn Schmiedebergs Arch Pharmacol Review Article While the COVID-19 pandemic also affected the work of regulatory authorities, the US Food and Drug Administration approved a total of 53 new drugs in 2020, one of the highest numbers in the past decades. Most newly approved drugs related to oncology (34%) and neurology (15%). We discuss these new drugs by level of innovation they provide, i.e., first to treat a condition, first using a novel mechanisms of action, and “others.” Six drugs were first in indication, 15 first using a novel mechanism of action, and 32 other. This includes many drugs for the treatment of orphan indications and some for the treatment of tropical diseases previously neglected for commercial reasons. Small molecules continue to dominate new drug approvals, followed by antibodies. Of note, newly approved drugs also included small-interfering RNAs and antisense oligonucleotides. These data show that the trend for declines in drug discovery and development has clearly been broken. Springer Berlin Heidelberg 2021-04-16 2021 /pmc/articles/PMC8051285/ /pubmed/33864098 http://dx.doi.org/10.1007/s00210-021-02085-3 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Review Article
Kayki-Mutlu, Gizem
Michel, Martin C.
A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2020
title A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2020
title_full A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2020
title_fullStr A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2020
title_full_unstemmed A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2020
title_short A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2020
title_sort year in pharmacology: new drugs approved by the us food and drug administration in 2020
topic Review Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8051285/
https://www.ncbi.nlm.nih.gov/pubmed/33864098
http://dx.doi.org/10.1007/s00210-021-02085-3
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