FDA approves AstraZeneca’s drug to prevent RSV in babies and toddlers

FDA

FDA approves AstraZeneca’s drug to prevent RSV in babies and toddlers

Today the FDA approved Beyfortus to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and in children up to 24 months of age who are vulnerable to severe RSV disease through their second RSV season. In most parts of the United States, RSV circulation is seasonal, usually starting during the fall and peaking in the winter. It is transmitted through close contact with someone who is infected. 

“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, M.D., M.P.H., director of the Office of Infectious Diseases in the FDA’s CDER. “Today’s approval addresses the great need for products to help reduce the impact of RSV disease on children, families and the health care system.”

Beyfortus, which received FDA Fast Track for this designation, is a monoclonal antibody with activity against RSV. Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses. 

Source: FDA email alert