FDA extends review of REGEN-COV for use on non-hospitalized and prophylaxis COVID-19 patients by three months

Due to discussions between the U.S. Food and Drug Administration (FDA) and Regeneron Pharmaceuticals, Inc. over pre-exposure prophylactic use, the FDA will extend the review of a Biologics License Application (BLA) for REGEN-COV as a COVID-19 treatment for three months.

Regeneron seeks to use REGEN-COV – a cocktail of cairivimab and imdevimab – as a treatment for COVID-19 among non-hospitalized patients and as prophylaxis in certain others. It has submitted additional data on the prophylaxis front for the FDA, but the agency considered that a major amendment of the existing BLA, thus mandating a deadline extension to give it time for proper review. That was not accompanied by any demands for additional studies.

The Biomedical Advanced Research and Development Authority (BARDA) partially funded the development and manufacturing of REGEN-COV, and, until January 2022, it operated under an Emergency Use Authorization in the United States. However, at that time, the FDA excluded the drug’s use in geographic regions where infection or exposure was likely due to a variant not susceptible to the treatment. As variants have overtaken the original strain of the virus, REGEN-COV’s authorization was effectively rescinded for use in the United States and its territories.

The investigational monoclonal antibody therapy remains a focus for Regeneron, though, and the company has begun a first-in-human clinical trial of next generation antibodies better suited to currently circulating variants of concern.