July 17 (Reuters) - The U.S. Food and Drug Administration (FDA) said on Monday it had approved Sanofi (SASY.PA) and partner AstraZeneca's (AZN.L) antibody therapy to prevent respiratory syncytial virus (RSV) in infants and toddlers.
The therapy, branded Beyfortus, was approved for preventing lower respiratory tract disease in 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 such season.
The companies plan to make Beyfortus available in the United States ahead of the upcoming RSV season, Sanofi said, adding that it plans to share more information about the therapy's price closer to the season.
RSV is a leading cause of hospitalizations in infants and so far Swedish Orphan Biovitrum's (SOBIV.ST) treatment, Synagis, was the only approved preventive therapy in the United States for high-risk infants.
The therapy comes with warnings and precautions about serious hypersensitivity reactions, and should be given with caution to infants and children with clinically significant bleeding disorders, the FDA said.
Persons:
AstraZeneca's, Sanofi, Beyfortus, Bhanvi Satija, Shinjini Ganguli, Maju Samuel
Organizations:
U.S . Food, Drug Administration, Sanofi, American Academy of Pediatrics, FDA, Thomson
Locations:
U.S, United States, Bengaluru