AstraZeneca PLC and its partner Sanofi SA on Thursday said nirsevimab, their antibody against respiratory syncytial virus, has been approved for review by the US Food & Drug Administration for preventing RSV lower respiratory tract disease in newborns and infants up to 24 months of age.
RSV is a common contagious virus affecting the lungs and breathing passages, with no vaccine currently approved.
If approved in the US, nirsevimab will be available for the 2023/2024 RSV season.
Citing medical studies, AstraZeneca said RSV is the leading cause of hospitalisations for babies in the US under the age of one, with 75% of infants hospitalised having been born with no underlying conditions.
In November 2022, the drug was granted marketing authorisation in the EU for the prevention of RSV lower respiratory tract disease in newborns and infants under the name beyfortus.
By Tom Budszus, Alliance News reporter
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