The European Commission (EC) approved Beyfortus, jointly developed by AstraZeneca and Sanofi, for the prevention of a common and highly contagious type of respiratory infection in infants.
This long-acting therapy, which is also known as nirsevimab, was given marketing authorisation in the European Union (EU) for the prevention of disease from several infections caused by the Respiratory Syncytial Virus (RSV), said Sanofi.
In the United States, the product is still under regulatory review as a breakthrough therapy. Beyfortus was recommended for approval by the European Medicines Agency (EMA) in September 2022. RSV causes many hospitalisations and deaths across the globe each year in infants, but the complex molecular structure of the RSV and safety concerns have raised efforts to develop a vaccine since RSV was first discovered in 1956.
Several new options to protect babies will likely increase in the future. According to Pfizer, its experimental RSV vaccine was found effective in preventing serious RSV infections in infants when given to mothers in the second half of pregnancy.
AstraZeneca also developed another existing preventive option called Synagis, but it is only available for high-risk infants, and is sold by Swedish Orphan Biovitrum in the United States. This also required up to five injections to cover a RSV season.