FDA Approves Beyfortus™ as Prevention of RSV in Newborns and Children Up To 24 Months Old
The U.S. Food and Drug Administration has approved Sanofi and AstraZeneca’s Beyfortus™ (nirsevimab alip) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) 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.
Premature infants and those with chronic lung disease of prematurity or significant congenital heart disease are at highest risk for severe RSV disease. RSV is a virus that causes acute respiratory infection in individuals of all age groups. While most infants and young children experience mild, cold-like symptoms, some infants, especially with their first infection, develop lower respiratory tract disease such as pneumonia and bronchiolitis (swelling of the small airway passages in the lungs), that often leads to an emergency department or physician office visit.
In most parts of the U.S., RSV circulation is seasonal, typically starting during the fall and peaking in the winter; it is transmitted from person to person through close contact with someone who is infected. Approximately 1% to 3% of children under 12 months of age in the United States are hospitalized each year due to RSV, according to the American Academy of Pediatrics.
Sanofi and AstraZeneca plan to make Beyfortus available in the U.S. ahead of the upcoming 2023- 2024 RSV season. 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.
