Sanofi, AstraZeneca Respiratory Treatment Nirsevimab Biologics License Accepted by FDA
January 05 2023 - 02:55AM
Dow Jones News
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 edward.frankl@dowjones.com
(END) Dow Jones Newswires
January 05, 2023 02:40 ET (07:40 GMT)
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