Sanofi, AstraZeneca Respiratory Treatment Nirsevimab Biologics License Accepted by FDA

By Ed Frankl

Sanofi said Thursday that U.S. health authorities approved a license for its nirsevimab treatment developed jointly with AstraZeneca PLC against a respiratory-tract disease in infants.

The U.S. Food & Drug administration accepted the Biologics License Application for nirsevimab in the prevention of respiratory syncytial virus in newborns and infants, Sanofi said.

Nirsevimab is being developed by Sanofi and AstraZeneca and, if approved, would be the first protective option for the broad infant population, the Paris-based company said.

European Union and U.K. regulators have approved the treatment under accelerated review, Sanofi said.

Write to Ed Frankl at [e-mail]

(END) Dow Jones Newswires

01-05-23 0240ET