Ahead of FDA, EMA gives thumbs-up to AstraZeneca, Sanofi's RSV antibody for infants and newborns
The partnership between AstraZeneca and Sanofi paid off on Friday.
The two European Big Pharmas put out word that their jointly-developed antibody Beyfortus (nirsevimab) was given a positive marketing authorization recommendation by the EMA’s CHMP to prevent RSV lower respiratory tract disease in both newborns and infants. The approval is the first of its kind for infants and newborns.
RSV has been known as one of the more prevalent causes of infant death and was the leading cause of infant hospitalization in the US and Europe for a time in the late 1980s.
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