AstraZeneca/Sanofi’s monoclonal antibody has been recommended by a US Food and Drug Administration’s (FDA) panel of experts for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in infants born during or entering their first RSV season.
The Antimicrobial Drugs Advisory Committee (AMDAC) voted unanimously in favour of using nirsevimab in this age population and, in a separate 19 to two vote, the panel backed the therapy’s use in children aged up to two years who are vulnerable to severe disease through their second RSV season.
RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people recover within a week or two, young infants, older adults and individuals with certain chronic medical conditions are at a high risk for severe disease.
RSV is the leading cause of hospitalisation for infants aged under one year in the US, where around 75% of infants hospitalised for the virus are born at term with no underlying conditions.
If approved, nirsevimab would be the first preventive option specifically designed to protect the broad infant population through its first RSV season, the companies said.
AMDAC’s recommendation is supported by the nirsevimab clinical development programme spanning three pivotal late-stage clinical trials, including positive results from the phase 3 MELODY trial.
The study, which evaluated nirsevimab in healthy late pre-term and term infants entering their first RSV season, showed that a single dose of nirsevimab led to a sustained and consistent reduction in RSV LRTDs requiring medical care versus placebo.
Nirsevimab was generally well tolerated with a favourable safety profile that was consistent across all clinical trials, the companies said, and the overall rates of adverse events were comparable between nirsevimab and placebo.
The FDA will now consider the panel’s advice as it works towards completing its review of the antibody, with a decision expected in the third quarter of this year.
Iskra Reic, executive vice president, vaccines and immune therapies, AZ, said: “We are delighted that the ADAC has unanimously recognised the favourable benefit risk profile of nirsevimab as the first preventative option against RSV for a broad infant population.
“We look forward to continuing to work with the FDA to complete their expedited review, and we hope to see nirsevimab available as soon as possible given the significant burden of RSV in infants.”