Novel drugs approved by the EMA, the FDA, and the MHRA in 2023: A year in review

In 2023, seventy novel drugs received market authorization for the first time in either Europe (by the EMA and the MHRA) or in the United States (by the FDA). Confirming a steady recent trend, more than half of these drugs target rare diseases or intractable forms of cancer. Thirty drugs are categor...

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Published inBritish journal of pharmacology Vol. 181; no. 11; pp. 1553 - 1575
Main Authors Papapetropoulos, Andreas, Topouzis, Stavros, Alexander, Steve P. H., Cortese‐Krott, Miriam, Kendall, Dave A., Martemyanov, Kirill A., Mauro, Claudio, Nagercoil, Nithyanandan, Panettieri, Reynold A., Patel, Hemal H., Schulz, Rainer, Stefanska, Barbara, Stephens, Gary J., Teixeira, Mauro M., Vergnolle, Nathalie, Wang, Xin, Ferdinandy, Péter
Format Journal Article
LanguageEnglish
Published England Blackwell Publishing Ltd 01.06.2024
Wiley
Subjects
Cell therapy
CRISPR
Drug Approval
drug development
EMA
Europe
FDA
Human health and pathology
Humans
Life Sciences
Medication
MHRA
new drug approvals
Pharmaceutical sciences
Pharmacology
regulatory
United States
United States Food and Drug Administration
United States
Europe
EMA
drug development
FDA
new drug approvals
MHRA
regulatory
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Summary:In 2023, seventy novel drugs received market authorization for the first time in either Europe (by the EMA and the MHRA) or in the United States (by the FDA). Confirming a steady recent trend, more than half of these drugs target rare diseases or intractable forms of cancer. Thirty drugs are categorized as “first‐in‐class” (FIC), illustrating the quality of research and innovation that drives new chemical entity discovery and development. We succinctly describe the mechanism of action of most of these FIC drugs and discuss the therapeutic areas covered, as well as the chemical category to which these drugs belong. The 2023 novel drug list also demonstrates an unabated emphasis on polypeptides (recombinant proteins and antibodies), Advanced Therapy Medicinal Products (gene and cell therapies) and RNA therapeutics, including the first‐ever approval of a CRISPR‐Cas9‐based gene‐editing cell therapy.
Bibliography:Andreas Papapetropoulos and Stavros Topouzis contributed equally to this work.
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ISSN:0007-1188
1476-5381
1476-5381
DOI:10.1111/bph.16337