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FDA Approves Beyfortus for Prevention of Respiratory Syncytial Virus in Infants

Nirsevimab Found to Be Highly Effective in Phase 3 Trial

New Antibody Offers Hope for Reducing RSV Hospitalizations

The Food and Drug Administration (FDA) has approved Beyfortus (nirsevimab) for the prevention of respiratory syncytial virus (RSV) in all infants. RSV is a common contagious seasonal virus that will infect nearly all children by their second birthday. It is the leading cause of hospitalization in infants under 12 months of age. Beyfortus is a long-acting antibody that is designed to provide direct protection against RSV in newborns and infants. It is the first FDA-approved RSV prevention option for all infants. In a Phase 3 trial published in the New England Journal of Medicine, Beyfortus was found to be highly effective in preventing RSV-related lower respiratory tract infections (LRTIs) in infants. The trial enrolled over 15,000 infants and found that Beyfortus reduced the incidence of LRTIs by 74.5% compared to placebo. The FDA's Antimicrobial Drugs Advisory Committee (AMDAC) voted 11-1 in favor of approving Beyfortus. The committee concluded that the benefits of Beyfortus outweigh the risks and that it is a safe and effective option for preventing RSV in infants. The FDA's approval of Beyfortus is a major step forward in the fight against RSV. This new antibody offers hope for reducing RSV hospitalizations and improving the health of infants.