TY - JOUR
T1 - Novel drugs approved by the EMA, the FDA, and the MHRA in 2023
T2 - A year in review
AU - Papapetropoulos, Andreas
AU - Topouzis, Stavros
AU - Alexander, Steve P. H.
AU - Cortese‐Krott, Miriam
AU - Kendall, Dave A.
AU - Martemyanov, Kirill A.
AU - Mauro, Claudio
AU - Nagercoil, Nithyanandan
AU - Panettieri, Reynold A.
AU - Patel, Hemal H.
AU - Schulz, Rainer
AU - Stefanska, Barbara
AU - Stephens, Gary J.
AU - Teixeira, Mauro M.
AU - Vergnolle, Nathalie
AU - Wang, Xin
AU - Ferdinandy, Péter
N1 - Research Funding:
National Research, Development and Innovation Office of Hungary; National Heart Laboratory. Grant Number: RRF-2.3.1-21-2022-00003.
PY - 2024/3/22
Y1 - 2024/3/22
N2 - 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.
AB - 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.
KW - FDA
KW - MHRA
KW - EMA
KW - drug development
KW - new drug approvals
KW - regulatory
U2 - 10.1111/bph.16337
DO - 10.1111/bph.16337
M3 - Review article
SN - 0007-1188
JO - British Journal of Pharmacology
JF - British Journal of Pharmacology
ER -
