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

Andreas Papapetropoulos^{1

2}, Stavros Topouzis³, Steve P H Alexander⁴, Miriam Cortese-Krott^{5

6}, Dave A Kendall⁴, Kirill A Martemyanov⁷, Claudio Mauro⁸, Nithyanandan Nagercoil⁹, Reynold A Panettieri Jr¹⁰, Hemal H Patel¹¹, Rainer Schulz¹², Barbara Stefanska¹³, Gary J Stephens¹⁴, Mauro M Teixeira¹⁵, Nathalie Vergnolle¹⁶, Xin Wang¹⁷, Péter Ferdinandy^{18

19}

Affiliations

¹ Laboratory of Pharmacology, Department of Pharmacy, National and Kapodistrian University of Athens, Athens, Greece.
² Clinical, Experimental Surgery and Translational Research Center, Biomedical Research Foundation of the Academy of Athens, Athens, Greece.
³ Laboratory of Molecular Pharmacology Department of Pharmacy, University of Patras, Patras, Greece.
⁴ University of Nottingham, Nottingham, UK.
⁵ Myocardial Infarction Research Laboratory, Department of Cardiology, Pneumology, Angiology, Medical Faculty, Heinrich Heine University of Düsseldorf, Düsseldorf, Germany.
⁶ CARID, Cardiovascular Research Institute Düsseldorf, Düsseldorf, Germany.
⁷ University of Florida, Gainesville, Florida, USA.
⁸ Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.
⁹ Medicines and Healthcare products Regulatory Agency, London, UK.
¹⁰ Rutgers University, New Brunswick, New Jersey, USA.
¹¹ VA San Diego Healthcare System and University of California/San Diego, San Diego, CA, USA.
¹² University of Giessen, Giessen, Germany.
¹³ University of British Columbia, Vancouver, British Columbia, Canada.
¹⁴ University of Reading, Reading, UK.
¹⁵ Federal University of Minas Gerais, Belo Horizonte, Brazil.
¹⁶ IRSD, Université de Toulouse, INSERM, INRAE, ENVT, UPS, Toulouse, France.
¹⁷ University of Manchester, Manchester, UK.
¹⁸ Department of Pharmacology and Pharmacotherapy, Semmelweis University, Budapest, Hungary.
¹⁹ Pharmahungary Group, Szeged, Hungary.

PMID: 38519837
DOI: 10.1111/bph.16337

Free article

Review

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

Andreas Papapetropoulos et al. Br J Pharmacol. 2024 Jun.

Free article

. 2024 Jun;181(11):1553-1575.

doi: 10.1111/bph.16337. Epub 2024 Mar 22.

Authors

Affiliations

¹ Laboratory of Pharmacology, Department of Pharmacy, National and Kapodistrian University of Athens, Athens, Greece.
² Clinical, Experimental Surgery and Translational Research Center, Biomedical Research Foundation of the Academy of Athens, Athens, Greece.
³ Laboratory of Molecular Pharmacology Department of Pharmacy, University of Patras, Patras, Greece.
⁴ University of Nottingham, Nottingham, UK.
⁵ Myocardial Infarction Research Laboratory, Department of Cardiology, Pneumology, Angiology, Medical Faculty, Heinrich Heine University of Düsseldorf, Düsseldorf, Germany.
⁶ CARID, Cardiovascular Research Institute Düsseldorf, Düsseldorf, Germany.
⁷ University of Florida, Gainesville, Florida, USA.
⁸ Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.
⁹ Medicines and Healthcare products Regulatory Agency, London, UK.
¹⁰ Rutgers University, New Brunswick, New Jersey, USA.
¹¹ VA San Diego Healthcare System and University of California/San Diego, San Diego, CA, USA.
¹² University of Giessen, Giessen, Germany.
¹³ University of British Columbia, Vancouver, British Columbia, Canada.
¹⁴ University of Reading, Reading, UK.
¹⁵ Federal University of Minas Gerais, Belo Horizonte, Brazil.
¹⁶ IRSD, Université de Toulouse, INSERM, INRAE, ENVT, UPS, Toulouse, France.
¹⁷ University of Manchester, Manchester, UK.
¹⁸ Department of Pharmacology and Pharmacotherapy, Semmelweis University, Budapest, Hungary.
¹⁹ Pharmahungary Group, Szeged, Hungary.

PMID: 38519837
DOI: 10.1111/bph.16337

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.

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References

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

Affiliations

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

Authors

Affiliations

Abstract

References

REFERENCES

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Research Materials