Regeneron requests EUA from the FDA for coronavirus treatment


Medical technicians work at a drive-through coronavirus disease (COVID-19) testing facility at the Regeneron Pharmaceuticals company’s Westchester campus in Tarrytown, New York, September 17, 2020.

Brendan McDermid | Reuters

Regeneron’s stock price rose over 4% in pre-market trade Thursday, as it submitted an “emergency use authorization” (EUA) request to the U.S. Food and Drug Administration for its Covid-19 antibody treatment.

Its “REGN-COV2” monoclonal antibody coronavirus therapy is what President Donald Trump took last week after being diagnosed with the coronavirus. He has since described it as a “cure.” 

The biotech company published a statement Wednesday noting that “if an EUA is granted the (U.S.) government has committed to making these doses available to the American people at no cost and would be responsible for their distribution.”

At this time, there are doses available for approximately 50,000 patients, Regeneron said, “and we expect to have doses available for 300,000 patients in total within the next few months.”

REGN-COV2 is a combination of two monoclonal antibodies and was “designed specifically to block infectivity” of the virus (SARS-CoV-2) that causes Covid-19.

Trump was given an 8 gram dose of the antibody cocktail early in the course of his Covid-19 infection, despite it not being authorized by the FDA. 

Regeneron said preclinical studies have shown that REGN-COV2 reduced the amount of virus and associated damage in the lungs of non-human primates. The company has recently partnered with Roche to increase the global supply of REGN-COV2, if approved.

“If REGNCOV2 proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the U.S. (beyond the initial U.S. Government supply) and Roche will develop, manufacture and distribute it outside the U.S.,” the company said.



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