FDA Advisory Committee Recommends Nirsevimab for Infant RSV Prevention
A US Food and Drug Administration (FDA) advisory committee has unanimously recommended nirsevimab for preventing RSV lower respiratory tract disease in infants. If approved, it would be the first option designed to protect the broad infant population.
An advisory committee to the US Food and Drug Administration (FDA) has unanimously recommended nirsevimab, a drug developed by AstraZeneca and Sanofi, for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants. The committee also voted overwhelmingly in favor of its use in children up to 24 months vulnerable to severe RSV.
If approved by the FDA, which is expected in the third quarter of 2023, nirsevimab could be available in the United States before the 2023-2024 RSV season. The drug has the potential to protect a wide range of infants during their first RSV season, including those born healthy, preterm, or with underlying health conditions that increase their risk.
RSV is a highly contagious virus that can cause serious respiratory illness in infants. In the US, it is the leading cause of hospitalization for infants under one year of age. Approximately 75% of infants hospitalized for RSV in the US were born at term with no underlying health conditions.
Clinical trials supporting the recommendation demonstrated that a single dose of nirsevimab provided consistent and sustained efficacy in reducing RSV lower respiratory tract disease requiring medical care compared to placebo throughout the entire RSV season. The drug was found to be generally well-tolerated with a favorable safety profile, with most adverse events being mild or moderate.