AstraZeneca, Sanofi win first FDA nod for infant RSV

July 18, 2023

AstraZeneca and Sanofi’s single dose long-acting antibody, branded Beyfortus (nirsevimab), has been approved by the FDA for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants, marking the first U.S. approved RSV preventive option for a broad infant population.

Beyfortus is approved for infants born during or entering their first RSV season, and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. 

The approval follows a unanimous June 21 to 0 vote by the Antimicrobial Drugs Advisory Committee in favor of the vaccine's use in newborns and infants, and 19 to 2 vote in support of the drug for children up to 24 months who remain vulnerable to severe RSV disease through their second RSV season. 

According to the two drugmakers, Beyfortus will be available in the U.S. ahead of the upcoming 2023-2024 RSV season.

RSV is the leading cause of hospitalization for infants under the age of one in the U.S., averaging 16 times higher than the annual rate for flu. RSV infections can also be dangerous for older adults or those with underlying health issues. The CDC estimates that each year, between 60,000-160,000 older adults in the U.S. are hospitalized and 6,000-10,000 die due to RSV infection.

In one of the most anticipated regulatory decisions of the year, back in May, the FDA gave the OK to GSK’s Arexvy for use in individuals 60 years of age and older, marking the first-ever RSV vaccine for older adults to be approved globally. A month later, the agency approved Pfizer’s bivalent RSV vaccine, Abrysvo, for the prevention of LRTD in for the same patient population.

Abrysvo is also vying for approval for use in pregnant mothers. In May, an FDA Advisory Committee voted to back Abrysvo for infants younger than 6 months when administered during the second or third trimester of pregnancy in maternal patients. The vaccine’s BLA was granted priority review, and its regulatory action date is scheduled for August 21, 2023.