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

Andreas Papapetropoulos; Stavros Topouzis; Steve P.H. Alexander; Miriam Cortese-Krott; Dave A. Kendall; Kirill A. Martemyanov; Claudio Mauro; Nithyanandan Nagercoil; Reynold A. Panettieri; Hemal H. Patel; Rainer Schulz; Barbara Stefanska; Gary J. Stephens; Mauro M. Teixeira; Nathalie Vergnolle; Xin Wang; Péter Ferdinandy

doi:10.1111/bph.16337

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

Andreas Papapetropoulos
, Stavros Topouzis
, Steve P.H. Alexander
, Miriam Cortese-Krott
, Dave A. Kendall
, Kirill A. Martemyanov
, Claudio Mauro
, Nithyanandan Nagercoil
, Reynold A. Panettieri
, Hemal H. Patel
, Rainer Schulz
, Barbara Stefanska
, Gary J. Stephens
, Mauro M. Teixeira
, Nathalie Vergnolle
, Xin Wang
, Péter Ferdinandy

Rutgers Institute for Translational Medicine and Science

Rutgers, The State University

Research output: Contribution to journal › Review article › peer-review

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.

Original language	American English
Pages (from-to)	1553-1575
Number of pages	23
Journal	British Journal of Pharmacology
Volume	181
Issue number	11
DOIs	https://doi.org/10.1111/bph.16337
State	Published - Jun 2024

ASJC Scopus subject areas

Pharmacology

Keywords

EMA
FDA
MHRA
drug development
new drug approvals
regulatory

Access to Document

10.1111/bph.16337

Cite this

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

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

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.",

keywords = "EMA, FDA, MHRA, drug development, new drug approvals, regulatory",

author = "Andreas Papapetropoulos and Stavros Topouzis and Alexander, \{Steve P.H.\} and Miriam Cortese-Krott and Kendall, \{Dave A.\} and Martemyanov, \{Kirill A.\} and Claudio Mauro and Nithyanandan Nagercoil and Panettieri, \{Reynold A.\} and Patel, \{Hemal H.\} and Rainer Schulz and Barbara Stefanska and Stephens, \{Gary J.\} and Teixeira, \{Mauro M.\} and Nathalie Vergnolle and Xin Wang and P{\'e}ter Ferdinandy",

note = "Publisher Copyright: {\textcopyright} 2024 The Authors. British Journal of Pharmacology published by John Wiley \& Sons Ltd on behalf of British Pharmacological Society.",

year = "2024",

month = jun,

doi = "10.1111/bph.16337",

language = "American English",

volume = "181",

pages = "1553--1575",

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Papapetropoulos, A, Topouzis, S, Alexander, SPH, Cortese-Krott, M, Kendall, DA, Martemyanov, KA, Mauro, C, Nagercoil, N, Panettieri, RA, Patel, HH, Schulz, R, Stefanska, B, Stephens, GJ, Teixeira, MM, 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, vol. 181, no. 11, pp. 1553-1575. https://doi.org/10.1111/bph.16337

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

PY - 2024/6

Y1 - 2024/6

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 - EMA

KW - FDA

KW - MHRA

KW - drug development

KW - new drug approvals

KW - regulatory

UR - https://www.scopus.com/pages/publications/85189149169

UR - https://www.scopus.com/pages/publications/85189149169#tab=citedBy

U2 - 10.1111/bph.16337

DO - 10.1111/bph.16337

M3 - Review article

C2 - 38519837

SN - 0007-1188

VL - 181

SP - 1553

EP - 1575

JO - British Journal of Pharmacology

JF - British Journal of Pharmacology

IS - 11

ER -

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

Abstract

ASJC Scopus subject areas

Keywords

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