FDA Approves Beyfortus™ (Nirsevimab-Alip) for Infant Protection Against RSV Disease

Tuesday, July 18, 2023

The U.S. Food and Drug Administration (FDA) has officially approved Beyfortus™ (Nirsevimab-Alip), a collaboration between Sanofi and AstraZeneca, for protecting newborns and infants against respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD). This approval covers infants born during or entering their first RSV season and children up to 24 months old who are at risk of severe RSV disease in their second RSV season. The companies plan to make Beyfortus available in the United States prior to the upcoming 2023-2024 RSV season.

RSV is the leading cause of hospitalization for infants under the age of one in the United States, with hospitalization rates around 16 times higher than those for influenza. Every year, an estimated 590,000 cases of RSV disease in infants under one require medical care, including visits to physicians, urgent care facilities, emergency rooms, and hospitals. Beyfortus is a monoclonal antibody that has been approved for passive immunization, providing safe and effective protection for all infants during their first RSV season. This approval marks a significant step in reducing the burden of severe respiratory disease caused by RSV, particularly among vulnerable populations.

Beyfortus has demonstrated a favorable safety profile throughout its clinical trials, with similar rates of adverse events compared to the placebo. The majority of adverse events reported were mild to moderate in severity, including rash and injection site reactions. Notably, Beyfortus has already received approval in the European Union (October 2022), Great Britain (November 2022), and Canada (April 2023), with ongoing regulatory reviews in progress in China, Japan, and other countries.

In the United States, Beyfortus is administered as a single-dose, long-acting antibody, aiming to prevent RSV lower respiratory tract disease in all infants during their first RSV season. It is also indicated for children up to 24 months of age who remain at risk of severe RSV disease during their second RSV season.



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