Regeneron Applies for Emergency Use Authorization for REGN-COV2

Riding on the success of its Phase 3 trials and the publicity around President’s Trump treatment with REGN-COV2, Regeneron has applied for Emergency Use Authorization to make this available approximately 50,000 patients, and expects to have doses available for 300,000 patients in total within the next few months.

Details from Regeneron are available here.

Statement on REGN-COV2 Emergency Use Authorization Request

Subsequent to our discussions with regulatory authorities, we have submitted a request to the U.S. Food and Drug Administration for an Emergency Use Authorization (EUA) for our REGN-COV2 investigational antibody combination for COVID-19. Under our agreement with the U.S. 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 we expect to have doses available for 300,000 patients in total within the next few months.

About REGN-COV2
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, as detailed in Science. Preclinical studies have shown that REGN-COV2 red

Regeneron’s COVID-19 Center

Regeneron Applies for Emergency Use Authorization for REGN-COV2
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