FDA Delays Decision on Regeneron/Roche COVID Antibody Therapy

The U.S. Food and Drug Administration has extended by three months its review of Regeneron Pharmaceuticals Inc's application for the full approval of its COVID-19 antibody therapy, the U.S. drugmaker said on Thursday.

Before making its decision, the health agency wants to look at additional data submitted by Regeneron on using the antibody cocktail as a preventive treatment.

The FDA has not asked for any extra studies to complete its review and will now decide on the drug by July 13, Regeneron said.

Regeneron's "cocktail" of two monoclonal antibodies, casirivimab and imdevimab, had received an emergency use authorization in the United States in late 2020 to treat patients who were 12 years and older with mild-to-moderate COVID-19.

The therapy, called REGEN-COV, was later also authorized in the country for the prevention of COVID-19 in certain people exposed to an infected individual, or who were at high risk of such exposure.

However, data showed that REGEN-COV and a rival monoclonal antibody drug from Eli Lilly were unlikely to be effective against the highly contagious Omicron coronavirus variant. That led the U.S. FDA to revise the emergency use authorizations for both therapies to limit their use.

Regeneron is collaborating with Roche, which is primarily responsible for the development and distribution of the treatment outside the United States.