Regeneron CEO Hopes for FDA Authorization of its COVID-19 Antibody Cocktail ‘Soon’

In an investor call yesterday, Regeneron CEO Leonard Schleifer said he hoped for an early decision by the FDA on an Emergency Use Authorization (EUA) of the company’s COVID-19 antibody cocktail treatment REGN-COV2.

“We expect action in the relative near future, but there's no guarantee that will come. The FDA is doing a very careful analysis,” Schleifer said.

The FDA has been reviewing the EUA for about a month and Regeneron is seeking emergency use approval for nonhospitalized COVID-19 patients.

Data from Regeneron’s phase2/3 trial of REGN-COV2 showed the treatment significantly reduced viral load as well as the number of medical visits needed by nonhospitalized patients (DID, Oct. 30). The results showed the antibody cocktail cut medical visits by 57 percent through day 29.

President Trump received the antibody cocktail last month for treatment of COVID-19 along with the corticosteroid dexamethasone and Gilead Sciences’ antiviral treatment remdesivir (DID, Oct. 5). — Jason Scott