AstraZeneca and Sanofi have received unanimous backing from the FDA’s Antimicrobial Drugs Advisory Committee for their respiratory syncytial virus (RSV) antibody, nirsevimab, for use in the pediatric setting. Nirsevimab is an investigational long-acting antibody that targets and binds to the part of the RSV virus that attaches to the host’s cells. If approved, nirsevimab would become the first immunization option specifically designed to protect all infants through their first RSV season. Pfizer also has an investigational vaccine for RSV which won backing from the Vaccines and Related Biological Products Advisory Committee last month. The panel of external experts agreed that the immunizing antibody had a favorable benefit-risk profile for the prevention of RSV-associated lower respiratory tract disease in infants who are born during or are entering their first RSV season.
Keywords: AstraZeneca, Sanofi, FDA, pediatric, RSV antibody
In a landmark decision by the FDA’s Antimicrobial Drugs Advisory Committee on Thursday, AstraZeneca and Sanofi's respiratory syncytial virus (RSV) antibody nirsevimab was given unanimous approval for use in pediatric settings. The drug is intended to be used as a preventative measure against RSV-associated