Posted by Michael Wonder on 14 Oct 2021
FDA accepts Regen-Cov (casirivimab and imdevimab) for priority review for treatment and prophylaxis of COVID-19
14 October 2021 - European Medicines Agency also announced earlier this week it would review marketing authorisation application for the antibody cocktail.
Regeneron Pharmaceuticals today announced that the U.S. FDA has accepted for priority review a biologics license application for Regen-Cov (casirivimab and imdevimab) to treat COVID-19 in non-hospitalised patients and as prophylaxis in certain individuals.
The FDA has assigned a target action date of 13 April 2022 and informed us that they currently are planning to hold an advisory committee meeting to discuss this application in advance of that date.
