FDA extends review of Regeneron's REGEN-COV to treat/prevent COVID-19
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The U.S. Food and Drug Administration (FDA) extended the review period by three months of Regeneron Pharmaceuticals' (NASDAQ:REGN) application seeking approval of REGEN-COV to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals.
The company said the extension is due to ongoing discussions with the FDA on pre-exposure preventive use, for which it has submitted additional data from a completed prophylaxis trial that the FDA has accepted for review.
The company added that the FDA considered the submission of these additional data to be a major amendment to the Biologics License Application (BLA) and now expects to make decision by July 13.
Regeneron (REGN) noted that the FDA has not requested any new studies to complete its review of the current BLA at this time.
The company said the monoclonal antibody therapy REGEN-COV (casirivimab and imdevimab) is not currently authorized for use in any U.S. states or territories after the FDA amended an emergency use authorization (EUA) for the drug in January.
The EUA was amended on the grounds that the treatment was not vey effective against a variant which was prevailing in the U.S. then.
In March, the World Health Organization also recommended the use of REGEN-COV only in people who are not infected with Omicron, as evidence suggested that the therapy was ineffective against the variant.