(Reuters) – The U.S. Food and Drug Administration’s staff reviewers on Tuesday raised no new concerns on Sanofi and partner AstraZeneca’s experimental therapy to prevent respiratory syncytial virus (RSV) infections in infants.
The RSV prevention antibody, nirsevimab, showed an overall favorable safety profile in clinical trials, FDA staff said in documents published ahead of the health regulator’s advisory committee meeting on Thursday.
The companies are seeking approval for use of the therapy in infants and children up to 24 months of age to protect them against lower respiratory tract disease from the virus.
While RSV generally causes a mild illness, infants are among those at the greatest risk of severe disease from the highly contagious virus. One to two out of every 100 babies below six months of age with RSV infection may need to be hospitalized, according to government data.
(Reporting by Raghav Mahobe and Mariam Sunny in Bengaluru; Editing by Krishna Chandra Eluri and Shounak Dasgupta)
