The FDA needs to review additional data from a trial that assessed REGEN-COV for the prevention of COVID-19. The new PDUFA date is July 13, 2022.
The FDA has extended by three months its review of the biologics license application (BLA) for REGEN-COV (casirivimab and imdevimab) to treat COVID-19 in non-hospitalized patients and a preventive medication for some people.
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 BLA and has provided a new target action date of July 13, 2022. The FDA has not requested any new studies.
REGEN-COV contains two monoclonal antibodies that are designed to block infection of SARS-CoV-2. It first became available in November 2020 under an emergency use authorization, but in January 2022 the FDA limited the EUA in the areas where the omicron variant of the virus was circulating saying the treatment was not effective against this variant. Currently, REGEN-COV is not currently authorized in the United States.
Regeneron submitted data for full approval in October 2021. This was based on two positive phase 3 trials involving more than 6,000 patients in non-hospitalized patients and as prophylaxis.