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Regeneron’s COVID-19 Treatment Granted FDA Approval, Begins Shipping

Photo courtesy of Regeneron

The local pharma co. is beginning to supply Americans with the same antibody cocktail that Donald Trump received earlier this year.

Regeneron Pharmaceuticals recently announced that it has been awarded a $450 million contract to manufacture and supply an anti-viral antibody cocktail it has been developing for the treatment and prevention of COVID-19 infection.

The double antibody cocktail, called REGN-COV2, passed Phase 2 and 3 clinical trials for the treatment of COVID-19 and Phase 3 trials for the prevention of the virus this summer, before being granted compassionate care authorization to treat President Donald Trump, who tested positive for the virus in October following several “superspreader” events held at the White House.

The Biomedical Advanced Research and Development Authority (BARDA) and the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense awarded this agreement to the biotechnology company as part of Operation Warp Speed, the program to fast track the nation’s coronavirus response.

REGN-COV2 will be made available immediately in the United States now that clinical trials among hospitalized patients have proven successful, and the U.S. Food and Drug Administration (FDA) has granted its sign-off.

Since early spring, Regeneron has been increasing manufacturing of the cocktail, a combination of two potent, non-competing and virus-neutralizing antibodies, using the same method it developed for rapid development of a highly-effective novel Ebola treatment last year.

Read More: Regeneron Develops Promising New Ebola Treatment

Leonard S. Schleifer, M.D., Ph.D., Co-Founder, President and CEO of Regeneron, says the company’s thirty years of investment in this type of antibody discovery and development technology have enabled them to move quickly on the REGN-COV2 program.

“We made the decision early on to begin large-scale manufacturing at our own risk in order to ensure that product would be available immediately if our clinical trials prove successful and an Emergency Use Authorization is granted,” he says. “This manufacturing and supply agreement with BARDA and the Department of Defense could help REGN-COV2 reach many people quickly, hopefully helping to change the course of this deadly and still-raging pandemic.”

The contract covers a fixed number of bulk lots that may be completed in fall of 2020: 30,000 doses of the drug have begun shipping on the order of the Department of Health & Human Services, with 300,000 additional doses expected by the end of January 2021. An additional 420,000 to 1.3 million preventative doses may come farther down the line. The government will be responsible for making doses from these lots available to Americans at no cost and would be responsible for distribution.