FDA approves new drug to protect infants, toddlers from RSV

Regulators on Monday approved a new drug aimed at protecting babies and toddlers against a respiratory virus that puts tens of thousands of young children in hospitals each year.

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The Food and Drug Administration gave the green light to AstraZeneca and Sanofi’s Beyfortus to prevent respiratory syncytial virus — commonly known as RSV — in babies and some toddlers. The virus circulates seasonally, typically starting in the fall and peaking in winter. It poses a particular risk to premature infants, those who are 6 months old and younger and children younger than 2 years old who have chronic lung disease or congenital heart disease, officials said.

Beyfortus was approved for babies going into their first RSV season and toddlers as old as 24 months who are vulnerable to severe RSV disease, according to the FDA.

John Farley, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, noted Monday that the virus “results in a large number of emergency department and physician office visits each year.” As many as 80,000 children under the age of 5 are estimated to be hospitalized annually due to RSV, according to the Centers for Disease Control and Prevention. It is the leading cause of hospitalization for infants under the age of 1 nationwide, officials with AstraZeneca said.

The U.S. saw a severe RSV surge last fall that put heavy pressure on hospitals across the country, according to researchers. Data from the CDC shows that in the 2022-2023 season, about 51 of every 100,000 people were hospitalized in connection with the virus, with children aged 4 and younger seeing the largest spike.

“Today’s approval marks an unprecedented moment for protecting infant health in the U.S., following an RSV season that took a record toll on infants, their families, and the U.S. healthcare system,” Thomas Triomphe, Safoni’s executive vice president for vaccines, said Monday in a statement.

RSV can cause acute respiratory infections in people of all age groups. Infants and young children typically experience mild, cold-like symptoms, though some can develop lower respiratory tract diseases like pneumonia and bronchiolitis that necessitate a doctor’s visit, according to the FDA.

The FDA’s approval comes after three trials found that Beyfortus reduced the risk of RSV lower respiratory tract infection by as much as 75% when compared to a placebo.

Beyfortus will be available in the U.S. ahead of the upcoming 2023-2024 RSV season, according to AstraZeneca. It can be administered at the start of the season or at birth for children who are born in the middle of the season, with protection that lasts for five months, company officials said.