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

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

Abstract

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.

Citation

Papapetropoulos, A., Topouzis, S., Alexander, S. P. H., Cortese‐Krott, M., Kendall, D. A., Martemyanov, K. A., Mauro, C., Nagercoil, N., Panettieri, R. A., Patel, H. H., Schulz, R., Stefanska, B., Stephens, G. J., Teixeira, M. M., Vergnolle, N., Wang, X., & Ferdinandy, P. (2024). Novel drugs approved by the EMA, the FDA, and the MHRA in 2023: A year in review. British Journal of Pharmacology, 181(11), 1553-1575. https://doi.org/10.1111/bph.16337

• Journal Article Type: Review
• Acceptance Date: Jan 29, 2024
• Online Publication Date: Mar 22, 2024
• Publication Date: Mar 22, 2024
• Deposit Date: Apr 15, 2024
• Publicly Available Date: Apr 16, 2024
• Journal: British Journal of Pharmacology
• Print ISSN: 0007-1188
• Electronic ISSN: 1476-5381
• Publisher: Wiley
• Peer Reviewed: Not Peer Reviewed
• Volume: 181
• Issue: 11
• Pages: 1553-1575
• DOI: https://doi.org/10.1111/bph.16337
• Keywords: FDA, MHRA, EMA, drug development, new drug approvals, regulatory
• Public URL: https://nottingham-repository.worktribe.com/output/33012819
• Publisher URL: https://bpspubs.onlinelibrary.wiley.com/doi/10.1111/bph.16337
• Additional Information: Received: 2024-01-27; Accepted: 2024-01-29; Published: 2024-03-22