The Food and Drug Administration announced Monday that it has approved the new drug Beyfortus in an effort to fight the spread of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in newborns and toddlers.
The approval to AstraZeneca – which is involved in producing the drug – comes about two months after the FDA green-lit the first RSV vaccine for people 60 years and older.
“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,” John Farley, the director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, said in a statement. “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.”
The FDA says that “while most infants and young children experience mild, cold-like symptoms” after contracting RSV, “some infants, especially with their first infection, develop lower respiratory tract disease such as pneumonia and bronchiolitis.”
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“Premature infants, and those with chronic lung disease of prematurity or significant congenital heart disease, are at highest risk for severe RSV disease,” the FDA added. “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.”
The FDA described Beyfortus as a “monoclonal antibody with activity against RSV” and one dose administered by injection prior to or during RSV season – which begins in the fall and spikes during the winter months – “may provide protection.”
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Its approval Monday is for “neonates and infants born during or entering their first RSV season, and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.”
In May, the FDA approved Arexvy to protect those 60 years and older against RSV.
“Older adults, in particular those with underlying health conditions, such as heart or lung disease or weakened immune systems, are at high risk for severe disease caused by RSV,” Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research in Silver Spring, Maryland, said at the time.
Fox News’ Melissa Rudy contributed to this report.
