FDA Approves Antibody to Protect Infants Against RSV

The U.S. Food and Drug Administration (FDA) has approved nirsevimab to protect newborns from respiratory syncytial virus (RSV). The drug, which will be sold under the brand name Beyfortus, is a ready-made antibody that can bind to the virus and block it from infecting healthy cells. Rather than a vaccine that prompts the body to make antibodies to defend against pathogens, with nirsevimab, the immune system doesn’t have to make anything. It’s given as a single injection to an infant before RSV season, which usually peaks in the fall and winter months. The FDA approval also allows a second injection for infants up to 24 months of age who remain vulnerable through their second RSV season.

“RSV can cause serious disease in infants and some children and results in a large number of emergency department and physician office visits each year,” said John Farley, MD, MPH, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research. “Today’s approval addresses the great need for products to help reduce the impact of RSV disease on children, families and the healthcare system.”