AstraZeneca BLA for RSV Prevention in Infants

FDA has accepted for review an AstraZeneca BLA for nirsevimab for preventing respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants entering or during their first RSV season, and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. The therapy is being developed in collaboration with Sanofi. The agency has set a user fee review action target date for the third quarter, and if approved the therapy will be available for the 2023/2024 RSV season, the company says.

The submission is based on data from the MELODY Phase 3 trial that showed a reduction in the incidence of medically-attended lower respiratory tract RSV infections by 74.5% vs. placebo. In November, the European Union granted nirsevimab a marketing authorization under the tradename Beyfortus.