The US FDA Extends BLA Review for Regeneron’s REGEN-COV for the Treatment and Prophylaxis of COVID-19
Shots:
- The US FDA has extended by three months its review of the BLA for REGEN-COV (casirivimab and imdevimab) to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals
- The decision comes after Regeneron submitted additional data from a prophylaxis trial. The FDA considers these additional data to be a Major Amendment to the BLA and has provided a new PDUFA date of July 13, 2022
- The US FDA has not requested any new studies to complete its review of the current BLA at this time
Ref: Regeneron | Image: Regeneron
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