EU approves Beyfortus for respiratory syncytial virus.- AstraZeneca + Sanofi
AstraZeneca and Sanofi’s Beyfortus (nirsevimab) has been approved in the European Union (EU) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season.
Beyfortus is the first and only single-dose RSV passive immunisation for the broad infant population, including those born healthy, at term or preterm, or with specific health conditions.
The approval was based on results from the Beyfortus clinical development programme, including the MELODY Phase III, MEDLEY Phase II/III and Phase IIb trials and follows the recommendation by The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency in September 2022.
In the pivotal MELODY efficacy trial, Beyfortus met its primary endpoint of reducing the incidence of medically attended lower respiratory tract infections (LRTI) caused by RSV by 74.5% (95% CI 49.6, 87.1; p<0.001) vs. placebo through day 151 (a typical rsv season) with a single dose. beyfortus 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.></0.001)>
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