(Reuters) – U.S. Food and Drug Administration said on Monday it had approved Sanofi and partner AstraZeneca’s antibody therapy to prevent respiratory syncytial virus (RSV) in infants and toddlers.
The therapy, branded as Beyfortus, was approved for preventing lower respiratory tract disease in infants 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.
RSV is a leading cause of hospitalizations in infants and so far, Swedish Orphan Biovitrum’s treatment, Synagis, was the only approved preventive therapy in the United States for high-risk infants.
Unlike Synagis, which is given as monthly injections, Beyfortus is a long-acting therapy that can be given once every season to prevent infection regardless of additional medical conditions in infants.
(Reporting by Bhanvi Satija and Raghav Mahobe in Bengaluru; Editing by Shinjini Ganguli)
