The FDA has approved nirsevimab-alip (Beyfortus; Sanofi and AstraZeneca) for preventing respiratory syncytial virus (RSV)-associated lower respiratory tract disease in neonates and infants born during or entering the first RSV season, and in children up to 2 years old who remain vulnerable to severe RSV disease through their second RSV season.
RSV circulation in the US typically starts in the fall and peaks in winter, causing mild symptoms in most infants but potentially leading to lower respiratory tract disease like pneumonia and bronchiolitis in some cases. Premature infants and those with certain medical conditions are at higher risk for severe RSV disease.
The monoclonal antibody nirsevimab-alip can be administered as a single intramuscular injection to provide protection.
Clinical trials showed it reduced the risk of medically attended RSV – associated lower respiratory tract infection by approximately 70% to 75% compared to placebo. Adverse effects may include rash and injection site reactions.
This approval addresses the need for preventing serious RSV-related respiratory diseases in children and reducing the burden on healthcare systems.