Regeneron Says FDA Extends Review Of BLA For REGEN-COV By 3 Months

Regeneron Pharmaceuticals, Inc. (REGN) said on Thursday that the U.S. Food and Drug Administration or FDA has extended its review of the Biologics License Application or BLA by three months for REGEN-COV, a combination of Casirivimab and Imdevimab.

REGEN-COV is an investigational monoclonal antibody therapy to treat Covid-19 in non-hospitalized patients and as prophylaxis in certain individuals.

The new move follows the firm's ongoing discussions with the Federal Agency 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 drug maker also said, 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.

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