A panel of outside advisers to the U.S. Food and Drug Administration (FDA) voted in favor of approving a preventative antibody treatment for respiratory syncytial virus (RSV) for in newborns and infants.
The unanimous vote by 21 members of the FDA’s Antimicrobial Drugs Advisory Committee (AMDAC) on Thursday brings the monoclonal antibody, nirsevimab, closer to final approval by the FDA.
All on the advisory panel agreed that benefits of the drug, nirsevimab, outweigh the risks in preventing RSV infections for newborns and infants in their first RSV season.
In a separate 19-2 vote, the panel backed the therapy’s use in children aged up to two years who are vulnerable to severe illness through their second RSV season….