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 three percent of children under the age of one 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 two 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.”
What is RSV?
RSV causes respiratory infections in people across all age groups, and two out of three infants are infected with RSV during their first year of life, according to Sanofi, the pharmaceutical company that will market the drug in the United States.
Last year, a surge of RSV cases flooded U.S. hospitals, caused by the lifting of social distancing restrictions that had prevented younger children from catching RSV during the pandemic.
Most infants and young children experience mild, cold-like symptoms, but some infections can evolve into severe cases of pneumonia and bronchiolitis (swelling of the small airway passages in the lungs).
RSV is the leading cause of hospitalization in infants younger than one, averaging 16 times higher than the annual rate for influenza, according to Sanofi. About three out of four infants hospitalized for RSV are born healthy and at term.
Premature infants or newborns with chronic lung disease of prematurity or significant congenital heart disease are