Sanofi gets European Commission nod for Beyfortus to prevent RSV disease in infants
RSV is the most common cause of LRTI, including bronchiolitis and pneumonia, in infants.;
Paris: Sanofi has announced that the European Commission has approved Beyfortus (nirsevimab) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season.
RSV is a common and highly contagious seasonal virus, infecting nearly all children by the age of two. Beyfortus is the single-dose RSV protective option for the broad infant population, including those born healthy, at term or preterm, or with specific health conditions. Beyfortus is being developed jointly by Sanofi and AstraZeneca.
Thomas Triomphe, Executive Vice President, Vaccines, 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."
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. The marketing authorization of Beyfortus marks a significant achievement for the scientific community and addresses a persistent, global unmet need in RSV prevention."
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