The European Commission (EC) approved AstraZeneca (NASDAQ:AZN) and Sanofi's (NASDAQ:SNY) antibody therapy Beyfortus to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season.
The British drugmaker said the EC is the first regulatory body to grant approval to Beyfortus (nirsevimab).
In addition, Beyfortus is also the first and only single-dose RSV passive immunization for the broad infant population, including those born healthy, at term or preterm, or with specific health conditions, AstraZeneca said in a press release on Friday.
"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," said Thomas Triomphe, executive vice president, Vaccines, Sanofi.
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion for approval of Beyfortus in September.
The approval was backed by data from programs, which included, a phase 3 study called MELODY, phase 2/3 trial, dubbed MEDLEY, and phase 2b trials.
AstraZeneca noted that Beyfortus is a long-acting antibody and the recommended dose is a single intramuscular injection of 50 mg for infants with body weight <5 kg and a single intramuscular injection of 100 mg for infants with body weight ≥5 kg.