AstraZeneca and Sanofi have secured the European Union (EU) marketing authorisation for Beyfortus (nirsevimab) to prevent a highly contagious type of respiratory infection in infants.
Beyfortus is a long-acting antibody, indicated for the prevention of lower respiratory tract disease caused by a respiratory syncytial virus (RSV) in newborns and infants, during their first RSV season.
The drug is being jointly developed by Sanofi and AstraZeneca, under an agreement signed in March 2017.
European Commission (EC) is the first regulatory agency to approve Beyfortus for the prevention of RSV lower respiratory tract disease in infants.
With the authorisation, Beyfortus becomes the first and only single-dose RSV passive immunisation available for the infant population, including those born healthy, at term or preterm, or with specific health conditions.
AstraZeneca vaccines and immune therapies executive vice president Iskra Reic, said: “Beyfortus is the first single-dose preventative option against the respiratory syncytial virus to gain approval in Europe and is also the first and only preventative option approved for a broad infant population.
Sanofi vaccines executive vice president Thomas Triomphe said: “Today is a landmark day for RSV prevention, as decades of research and development come together in the world’s first approval of a broadly protective option against respiratory syncytial virus disease.”
The EC approval is based on results from the Beyfortus clinical development programme.
It follows a positive recommendation by the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP), granted in September 2022.
The Beyfortus clinical development programme included Phase 3 MELODY, Phase 2/3 MEDLEY and Phase 2b clinical trials.
In the MELODY efficacy trial, Beyfortus met its primary endpoint of reducing 74.5% incidence of medically attended lower respiratory tract infections (LRTI) caused by RSV, compared to placebo.
Beyfortus also showed a safety and tolerability profile consistent with Synagis (palivizumab) in the MEDLEY Phase 2/3 trial, with similar adverse events between groups.
European Foundation for the Care of Newborn Infants (EFCNI) executive board and co-founder chairwoman Silke Mader said: “Respiratory syncytial virus represents a health threat among infants, and each year we see the impact it can have on families, healthcare providers and the healthcare system.
“At EFCNI, we are excited about the opportunity to expand prevention efforts to all infants, as we believe this can help ease the current emotional, physical and financial burdens of RSV.”
