Sanofi, AstraZeneca clinch first OK for RSV antibody — just as vaccines line up at regulators

The EU has officially stamped its seal of approval for nirsevimab, the antibody jointly developed by Sanofi and AstraZeneca to prevent RSV disease in infants.

Beyfortus will be the first single-dose protective option for newborns and infants during their first RSV season, the companies noted. While a different antibody, Synagis, has been on the market for two decades, it only covers a subset of infants at high risk of severe disease and it has to be administered monthly.

Cognizant of the controversy that Synagis’ price tag of up to $6,000 stirred, Sanofi has previously pledged to price Beyfortus differently and make it available to all infants.

Thomas Triomphe

Although respiratory syncytial virus usually causes only mild infections in adults, it can trigger serious illness for the youngest and oldest of society. While Sanofi and AstraZeneca worked on an antibody approach, multiple companies have aimed for vaccines, and there’s been a rush of progress recently, with GSK nabbing priority review at the FDA and Pfizer unveiling positive Phase III data suggesting, for the first time, it can protect newborns by vaccinating their mothers during pregnancy.

Globally in 2019, Sanofi and AstraZeneca said there were an estimated 26,300 in-hospital deaths of children younger than five years due to acute lower respiratory infections, of which RSV is a leading cause.

Thomas Triomphe, Sanofi’s EVP of vaccines, called it “a landmark day for RSV prevention.”

It remains to be seen how adoption of Beyfortus will shake out when vaccines also enter the fray. The EU is the first to approve the antibody, weeks after the EMA’s CHMP offered its positive recommendation.

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