FDA Approves New Drug to Protect Against RSV in Infants

FDA Approves New Drug to Protect Against RSV in Infants

Parents now have a new long-acting drug to protect their children against respiratory syncytial virus (RSV), a common germ that hospitalizes as many as 3% of children under the age of 1 in the United States each year.

The U.S. Food and Drug Administration on Monday approved Beyfortus (nirsevimab-alip) for the prevention of RSV in newborns and infants born during or entering their first RSV season.

The drug also is approved in children up to 2 years old who remain vulnerable to severe RSV disease 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,” Dr. John Farley, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, said in an agency news release. “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.”