A drug being developed jointly by Sanofi and AstraZeneca for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants was approved today (November 4).
The European Commission has approved Beyfortus which is so far the first and only broadly protective option against the virus.
Thomas Triomphe, executive vice president, vaccines at Sanofi, 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 RSV disease. Once launched, Beyfortus will offer parents the ability to help protect their babies during their first RSV season.”
Sanofi and AstraZeneca
RSV is a common and highly contagious seasonal virus, infecting nearly all children by the age of two. Beyfortus is the first and only single-dose RSV protective option for the broad infant population, including those born healthy, at term or preterm, or with specific health conditions.
Iskra Reic, vaccines and immune therapies unit, AstraZeneca, said: “Beyfortus is the first single-dose passive immunization against respiratory syncytial virus to gain approval in Europe and is also the first and only preventative option approved for a broad infant population.
“Today’s marketing authorization of Beyfortus marks a significant achievement for the scientific community and addresses a persistent, global unmet need in RSV prevention.”
Beyfortus for RSV
Silke Mader, co-founder of the European Foundation for the Care (EFCNI) of Newborn Infants, added: “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.”
The European Commission is the first regulatory body to grant approval to Beyfortus. The approval was based on results from the Beyfortus clinical development program, including the phase 3 Melody, phase 2/3 Medley and phase 2b clinical trials and follows the recommendation by The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency in September 2022.