Posted by Michael Wonder on 14 Apr 2022
U.S. FDA extends review of biologics license application for Regen-Cov (casivirimab and imdemivab) for treatment and prophylaxis of COVID-19
14 April 2022 - Regeneron continues to progress its next generation antibodies, and has initiated a first in human trial.
Regeneron Pharmaceuticals today announced that the U.S. FDA has extended by three months its review of the biologics license application for Regen-Cov (casirivimab and imdevimab) to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals.
The extension is due to ongoing discussions with the FDA on pre-exposure prophylactic use, for which Regeneron has submitted additional data from its completed prophylaxis trial that the FDA has accepted for review.
The FDA considers the submission of these additional data to be a major amendment to the biologics license application and has provided a new target action date of 13 July 2022.
