FDA extends review of Regeneron’s COVID treatment

April 15, 2022

The U.S. FDA is extending the review date for Regeneron Pharmaceuticals’ COVID-19 antibody cocktail back by three months. The decision was made after data showed it may help prevent infection.  

The data submitted showed that prevention could come via pre-exposure prophylactic use, a treatment strategy where medication is given to patients to stop a disease from spreading before those people are exposed to a virus or other disease-causer. The agency considers this new data to be a 'major amendment' to Regeneron’s current Biologics License Application. The new target action date is July 13.

REGEN-COV is a combination of casirivimab and imdevimab used to treat COVID-19 in non-hospitalized patients and as preventative treatment for some people.

Back in November 2020, REGEN-COV was granted Emergency Use Authorization from the FDA for patients in the U.S. At the time of the EUA, the antibody treatment was reported to be 81.6% effective at preventing COVID-19 infections up to eight months after being given to patients.

But the omicron variant set REGEN-COV back, making it virtually useless against the variant in the agency’s eyes. In January, the FDA yanked the EUA for the treatment in places where omicron was the prevailing variant. At the time, omicron was responsible for 99% of infections in the nation, meaning REGEN-COV lost authorization in all U.S. states, territories and jurisdictions.

Recently, the variants have shifted again with the BA.2 omicron subvariant accounting for 86.2% of all infections in the U.S. as cases continue to rise across the nation, but especially in northeastern states like New York, Connecticut and Massachusetts and Pennsylvania.

Eli Lilly’s antibody cocktail of bamlanivimab and etesevimab lost its emergency use authorization at the same time that REGEN-COV did over concerns of being ineffective against the omicron variant. Eli Lilly’s cocktail was granted an EUA in February 2021.