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Nirsevimab: First Approval

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Abstract

Nirsevimab (Beyfortus®), a long-acting intramuscular recombinant neutralising human IgG1ĸ monoclonal antibody to the prefusion conformation of the respiratory syncytial virus (RSV) F protein that has been modified with a triple amino acid substitution in the Fc region to extend the serum half-life, is being jointly developed by AstraZeneca and Sanofi for the prevention of RSV disease. The extended serum half-life allows administration of nirsevimab as a single dose to cover the RSV season. Nirsevimab was approved in the EU on 3 November 2022 and in the UK on 7 November 2022 for the prevention of RSV lower respiratory tract disease in neonates and infants during their first RSV season. This article summarizes the milestones in the development of nirsevimab leading to this first approval for the prevention of RSV disease in all infants.

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    Susan J. Keam

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  1. Susan J. Keam
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Correspondence to Susan J. Keam.

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The preparation of this review was not supported by any external funding.

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During the peer review process the developer and commercializing partner of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Susan J. Keam is a contracted employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

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This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch and beyond.

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Keam, S.J. Nirsevimab: First Approval. Drugs 83, 181–187 (2023). https://doi.org/10.1007/s40265-022-01829-6

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