Sanofi, AstraZeneca confirm FDA approves Beyfortus for RSV disease in infants

The U.S. Food and Drug Administration has approved Sanofi (SNY) and AstraZeneca’s (AZN) Beyfortus for the prevention of respiratory syncytial virus, or RSV, lower respiratory tract disease in newborns and infants born during or entering their first RSV season, and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season, the companies confirmed. “The companies plan to make Beyfortus available in the U.S. ahead of the upcoming 2023-2024 RSV season. RSV is the leading cause of hospitalization for infants under the age of one in the U.S., averaging 16 times higher than the annual rate for influenza. Each year, an estimated 590,000 RSV disease cases in infants under one require medical care, including physician office, urgent care, emergency room visits and hospitalizations,” the companies stated.