BRIEF—FDA delays Regeneron's REGEN-COV BLA review

Regeneron Pharmaceuticals revealed on Friday that the US Food and Drug Administration 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 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 BLA and has provided a new target action date of July 13, 2022.

The FDA has not requested any new studies to complete its review of the current BLA at this time.

The FDA first granted REGEN-COV an emergency use authorization in late 2020

Regeneron said the antibody cocktail generated sale of $2.3 billion in the fourth quarter of 2021, surpassing analyst expectations of $1.9 billion, after it completed final deliveries to the US government under a previous contract.