Posted by Michael Wonder on 17 Feb 2022
Nirsevimab EMA regulatory submission accepted under accelerated assessment for RSV protection in all infants
17 February 2022 - Nirsevimab is the first investigational long-acting antibody designed to protect all infants for the respiratory syncytial virus season with a single dose.
AstraZeneca’s marketing authorisation application for nirsevimab has been accepted under an accelerated assessment procedure by the EMA, for the prevention of medically attended lower respiratory tract infections in all infants through their first respiratory syncytial virus season.
