Sanofi, Astra win EU approval for prevention of infant RSV

Paris: The European Commission on Friday approved Sanofi and AstraZeneca's Beyfortus for the prevention of a common and highly contagious type of respiratory infections in infants.

The long-acting therapy, also known as nirsevimab, was given EU marketing authorisation for the prevention of disease from infections caused by the respiratory syncytial virus (RSV), Sanofi said in a statement.

In the United States, the product, in which Swedish Orphan Biovitrum also holds some rights, is still under regulatory review as a potential breakthrough therapy.

Beyfortus, given by intramuscular injection, was recommended for approval by the European Medicines Agency in September.

RSV causes thousands of hospitalisations and deaths globally each year in toddlers and the elderly, but the complex molecular structure of the virus and safety concerns have stymied efforts to develop a vaccine since the virus was first discovered in 1956.

An existing preventive option only for high-risk infants is Synagis, also developed by AstraZeneca but sold by Swedish Orphan Biovitrum in the United States. That requires up to five injections to cover a typical RSV season.

New options to protect babies will likely emerge. Pfizer said this week its experimental RSV vaccine was found effective for preventing severe infections in infants when given to expectant mothers in the second half of pregnancy.