Regeneron requests FDAA for EUA for coronovirus treatment


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

Brendan McDermid | Reuters

Regeneron’s share price rose more than 4% on Thursday in pre-market trade, as it submitted an “Emergency Use Authority” (EUA) request to the US Food and Drug Administration for its Kovid-19 antibody treatment.

Its “REGN-COV2” monoclonal antibody is coronavirus therapy that was taken by President Donald Trump last week after his diagnosis of coronovirus. He has since described it as a “cure”.

The biotech company published a statement on Wednesday, stating that “if an EUA (US) government is allowed, it will make US supplements available at no cost and be responsible for their delivery.”

At this time, doses are available for about 50,000 patients, Regeneron said, “and we expect the dose to be available for a total of 300,000 patients within the next few months.”

REGN-COV2 is a combination of two monoclonal antibodies and is “specifically designed to block infectives” of viruses (SARS-CoV-2) that cause Kovid-19.

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

Regeneron stated that preclinical studies showed that REGN-COV2 reduced the virus and associated damage in the lungs of non-human primates. Upon approval, the company recently partnered with Roche to increase global supply of REGN-COV2.

“If REGNCOV2 proves to be safe and effective in clinical trials and regulatory approval is granted, Regeneron will manufacture and distribute it in the US (beyond the initial US government supply) and Roche will develop, manufacture and manufacture it outside the US Will deliver, ”the company said. .

    .

Leave a Reply