Regeneron Pharmaceuticals Inc. said Thursday it has submitted an Emergency Use Authorization or EUA request to the U.S. Food and Drug Administration for its investigational COVID-19 treatment REGN-COV2.
Shares of the biotechnology company are gaining almost 4 percent in pre-market activity following the news.
Regeneron noted that if an EUA for the investigational antibody cocktail 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.
REGN-COV2, a combination of two monoclonal antibodies REGN10933 and REGN10987, was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19.
U.S. President Donald Trump was treated with REGN-COV2 and antiviral medication remdesivir after being recently diagnosed with COVID-19.
Trump was given “a single 8-gram dose of Regeneron’s polyclonal antibody cocktail as a precautionary measure”, according to White House physician Sean Conley. The president said the experimental drug helped him recover.
In late September, Regeneron had announced positive first data from a descriptive analysis of a seamless Phase 1/2/3 trial of REGN-COV2 in COVID-19 patients. REGN-COV2 rapidly reduced viral load and associated symptoms in infected COVID-19 patients.
Regeneron said that while REGN-COV2 doses are currently available for about 50,000 patients, it expects to have doses available for 300,000 patients in total within the next few months.
REGN-COV2’s development and manufacturing has been partly funded with federal funds from the Biomedical Advanced Research and Development Authority or BARDA, part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
Regeneron has recently partnered with Swiss drug maker Roche Group to increase the global supply of REGN-COV2.
Regeneron noted that if REGN-COV2 proves safe and effective in clinical trials and receives regulatory approvals, the company will manufacture and distribute it in the U.S. beyond the initial federal government supply. Roche will develop, manufacture and distribute the treatment outside the U.S.
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