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Beyfortus

Nirsevimab

An injectable single-dose biological therapy used to protect infants against RSV lower respiratory tract disease.

RSV-directed monoclonal antibody

Generic name

Nirsevimab

Brand name

Beyfortus

Drug class

Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody; Fusion Protein Inhibitors

Route

Intramuscular

Manufacturer

Sanofi Vaccines US Inc.

First FDA approval

17 Jul 2023

What Beyfortus is used for

BEYFORTUS is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in: Neonates and infants born during or entering their first RSV season. Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. BEYFORTUS is a respiratory syncytial virus (RSV) F protein-directed fusion inhibitor indicated for the prevention of RSV lower respiratory tract disease in: Neonates and infants born during or entering their first RSV season. ( 1 ) Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. ( 1 )

How it works

12.1 Mechanism of Action BEYFORTUS is a monoclonal antibody with anti-RSV activity [see Microbiology (12.4) ] .

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Sources: drug label, approval and manufacturer data from the U.S. FDA via the openFDA API; shortage status from the FDA Drug Shortage Database. This page is a plain-English summary for general information and is not medical advice. It is not exhaustive and may not reflect the latest label — always consult the official prescribing information and your clinician or pharmacist. Brand availability, indications and approvals differ between the US, EU/Ireland (EMA/HPRA) and other regions.