Positive topline results for nirsevimab in RSV

Sanofi and AstraZeneca’s (AZ) monoclonal antibody (mAb) nirsevimab reached its primary endpoint in a Phase III trial, demonstrating protection against respiratory syncytial virus disease (RSV) in healthy infants. Nirsevimab, an investigational extended half-life mAb is designed to protect infants entering their first RSV season, when they are at a higher risk for developing severe RSV disease. In the Phase III MELODY trial, nirsevimab reduced lower respiratory tract infections (LRTI) requiring medical attention due to RSV in healthy preterm and term infants. There were no clinically meaningful differences observed in the safety results between the nirsevimab and placebo groups, with the overall safety profile for nirsevimab in the trial remaining consistent with previously reported results. “Respiratory syncytial virus is the leading cause of hospitalisations in all infants,” said Jean-François Toussaint, global head of research and development, Sanofi Pasteur. “In fact, most hospitalisations occur in otherwise healthy infants born at term. It’s ...

• Source: drugdu
• 112
• April 26, 2021