USFDA accepts AstraZeneca’s BLA for nirsevimab to prevent RSV lower respiratory tract disease

The United States Food and Drug Administration (USFDA) has accepted AstraZeneca’s Biologics Licence Application (BLA) for nirsevimab for review to prevent 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, a statement from AstraZeneca notified.

Nirsevimab is being developed and commercialised by AstraZeneca in collaboration with Sanofi, and is the first single-dose preventative option for the broad infant population, including those born healthy, at term or pre-term, or with specific health conditions. The FDA has indicated it will work to expedite its review. The Prescription Drug User Fee Act date, the FDA target action date for its decision, is in the third quarter of 2023. If approved at that time, nirsevimab will be available in the US for the 2023/2024 RSV season, the statement said.

The statement also said that the BLA was based on results from the comprehensive nirsevimab clinical development programme, including the Melody phase-III (primary cohort and all subjects), Medley phase-II/III (first and second RSV season), and phase-IIb trials. Data from the Melody trial was published in the New England Journal of Medicine in March 2022 and demonstrated a reduction in the incidence of medically-attended Lower Respiratory Tract Infections (LRTIs) caused by RSV by 74.5 per cent (95 per cent CI 49.6, 87.1; p<0.001) vs. placebo through day 151 (a typical RSV season) with a single dose. Nirsevimab also demonstrated a comparable safety and tolerability profile to Synagis (palivizumab) in the Medley phase-II/III trial, with occurrence of Treatment Emergent Adverse Events (TEAEs) or Treatment Emergent Serious Adverse Events (TESAEs) similar between groups.

In November 2022, nirsevimab was granted marketing authorisation in the European Union for the prevention of RSV lower respiratory tract disease in newborns and infants during their first RSV season, under the name Beyfortus. Additional global regulatory submissions are underway, the statement concluded.