FDA Approves Breakthrough RSV Drug to Safeguard Infants and Toddlers
The FDA has approved Beyfortus (nirsevimab-alip), a new drug developed by AstraZeneca, for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates, infants, and children up to 24 months of age. RSV can cause serious respiratory infections in infants and young children, leading to hospitalizations. Beyfortus is a monoclonal antibody that provides protection against RSV when administered as a single intramuscular injection prior to or during RSV season. Clinical trials showed that Beyfortus reduced the risk of medically attended RSV lower respiratory tract infection by approximately 70% to 75% compared to placebo. Possible side effects include rash and injection site reactions.