The US Food and Drug Administration (FDA) has accepted AstraZeneca’s nirsevimab biologics licence application (BLA) for review to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in children aged up to 24 months.
It is being developed for children who remain vulnerable to their second RSV season and infants experiencing their first RSV season.
The regulatory body has assigned a Prescription Drug User Fee Act (PDUFA) date for its decision in the third quarter of this year.
If approved, nirsevimab will become the first single-dose preventative against RSV lower respiratory tract disease for the 2023/2024 RSV season in the US.
AstraZeneca Vaccines and Immune Therapies executive vice-president Iskra Reic said: “This decision brings us a step closer to delivering a first-in-class preventative option for a broad infant population in the US.
“If approved, we believe nirsevimab may transform the medical community’s approach to respiratory syncytial virus prevention in infants and we are committed to working with the FDA to support completion of the review as quickly as possible.”
The company stated that the BLA submission was based on the data obtained from the MELODY Phase III, MEDLEY Phase II/III, and Phase IIb trials.
Nirsevimab showed a 74.5% reduction in lower respiratory tract infections (LRTI) with a single dose compared to a placebo in the MELODY trial.
In the MEDLEY Phase II/III trial, the antibody showed a comparable tolerability and safety profile compared to Synagis (palivizumab).
The EU granted marketing authorisation to nirsevimab to prevent RSV lower respiratory tract disease in newborns and infants in November last year.