Nirsevimab unanimously recommended by FDA Advisory Committee for the prevention of RSV lower respiratory tract disease in infants
If approved, nirsevimab would be the first preventive option specifically designed to protect the broad infant population through its first RSV season. Across all clinical endpoints, a single dose of nirsevimab delivered consistent and sustained efficacy against RSV disease vs placebo.The US Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) has voted unanimously 21 to 0 that AstraZeneca and Sanofi’s nirsevimab has a favourable benefit risk profile for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and