FDA advisory committee recommends approval of nirsevimab for respiratory syncytial virus.- AstraZeneca and Sanofi

The Committee also voted 19 to 2 in support of nirsevimab’s favourable benefit risk profile for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

The AMDAC based its recommendation on the nirsevimab clinical development programme spanning three pivotal late-stage clinical trials, including results from the MELODY Phase III trial recently published in the New England Journal of Medicine. Across all clinical endpoints, a single dose of nirsevimab demonstrated sustained and consistent reduction in RSV LRTD requiring medical care vs placebo through the entire RSV season. Nirsevimab was generally well tolerated with a favourable safety profile that was consistent across all clinical trials. The overall rates of adverse events were comparable between nirsevimab and placebo and the majority of adverse events were mild or moderate in severity. The most common adverse events were rash, fever and injection site reactions.