Regeneron Requests FDA for Emergency Use Authorization for Its COVID-19 Antibody Cocktail

(Tarrytown, NY, USA) has submitted a request to the US Food and Drug Administration for an Emergency Use Authorization (EUA) for the company’s REGN-COV2 investigational antibody combination for COVID-19.

REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19. To develop REGN-COV2, Regeneron scientists evaluated thousands of fully-human antibodies produced by the company's VelocImmune mice, which have been genetically modified to have a human immune system, as well as antibodies identified from humans who have recovered from COVID-19. The two potent, virus-neutralizing antibodies that form REGN-COV2 bind non-competitively to the critical receptor binding domain of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population. Preclinical studies have shown that REGN-COV2 reduced the amount of virus and associated damage in the lungs of non-human primates.

If REGN-COV2 proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the US (beyond the initial US government supply) and Roche will develop, manufacture and distribute it outside the US. Under Regeneron’s agreement with the US government for the initial doses of REGN-COV2, if an EUA is granted the 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, and the company expects to have doses available for 300,000 patients in total within the next few months.

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Regeneron Pharmaceuticals, Inc.