Nirsevimab in the prevention of respiratory syncytial virus lower respiratory tract disease: a profile of its use

<p>  </p> <div><strong>Declarations</strong></div> <div><strong>Funding</strong> The preparation of this review was not supported by any external funding.</div> <div><strong>Authorship and conflict of interest</strong> M. Shirley is a salaried employee of Adis International Ltd/Springer Nature and declare(s) no relevant conflicts of interest. All authors contributed to this article and are responsible for its content.</div> <div><strong>Ethics approval, Consent to participate, Consent for publication, Availability of data and material, Code availability</strong> Not applicable.</div> <div>Additional information about this Adis Drug Review can be found <a href="http://www.springer.com/gp/adis/products-services/adis-journals-newsletters/adis-drug-reviews" target="_blank"><strong>here</strong></a>.</div> <p>Abstract</p> <p>Nirsevimab (Beyfortus™), a long-acting monoclonal antibody targeting the respiratory syncytial virus (RSV) fusion (F) protein, is the first prophylactic monoclonal antibody against RSV to be licensed for use in all infants in their first RSV season, and thus presents a highly valuable tool in the fight against RSV disease in children. Additionally, in the USA and Canada, nirsevimab is licensed for use in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. Data from randomized, double-blind, placebo-controlled clinical trials show that a single intramuscular dose of nirsevimab is efficacious in reducing the incidence of medically attended RSV lower respiratory tract (LRT) disease in healthy term and preterm infants through at least 150 days in their first RSV season. Pharmacokinetic data also support the efficacy of nirsevimab in infants at higher risk of severe RSV disease, including in the second RSV season with a second nirsevimab dose. Nirsevimab has an extended serum half-life, resulting in a duration of protection from a single dose which can cover a full typical RSV season. Nirsevimab is well tolerated, with low rates of reactogenicity, and can be administered concomitantly with childhood vaccines.</p> <p>© Springer Nature Switzerland AG 2023</p>