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FDA Grants Emergency Use Approval To Regeneron's COVID-19 Antibody Therapy

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Regeneron's investigational COVID-19 antibody therapy REGN-COV2, which was administrated to U.S. President Donald Trump, has received emergency use authorization or EUA from the U.S. Food and Drug Administration.

According to the biotechnology company, REGN-COV2 or REGEN-COV2, a combination of two monoclonal antibodies casirivimab and imdevimab, is the first antibody cocktail for COVID-19 to receive EUA.

Under U.S. government allocation program, the company will now make available around 300,000 initial doses of REGEN-COV2, at no cost to patients, as agreed in July as part of Operation Warp Speed.

Regeneron now expects to have REGEN-COV2 treatment doses ready for around 80,000 patients by the end of November, around 200,000 patients by the first week of January, and around 300,000 patients in total by the end of January 2021.

The company will immediately start shipping REGEN-COV2 to Amerisource Bergen, which will distribute the therapy as directed by the government.

Leonard Schleifer, President and Chief Executive Officer of Regeneron said, "... demand may exceed supply initially, making it even more critical that federal and state governments ensure REGEN-COV2 is distributed fairly and equitably to the patients most in need. In the first quarter of 2021, we expect to increase available REGEN-COV2 global supply as we continue our collaboration with Roche."

REGN-COV2 was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19.

The antibody cocktail casirivimab and imdevimab administered together are authorized for the treatment of mild to moderate COVID-19 in adults, as well as in pediatric patients at least 12 years of age and weighing at least 40 kg. It can be used in patients who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization.

In late September, Regeneron had announced positive trial data, noting that REGN-COV2 rapidly reduced viral load and associated symptoms in infected COVID-19 patients.

However, Casirivimab and imdevimab are not authorized for use in patients who are hospitalized or require oxygen therapy due to COVID-19, or for people currently using chronic oxygen therapy because of an underlying comorbidity who require an increase in baseline oxygen flow rate due to COVID-19.

Trump, after being diagnosed with COVID-19 recently, was treated with REGN-COV2 and antiviral medication remdesivir. According to White House physician Sean Conley, Trump was given a single 8-gram dose of Regeneron's polyclonal antibody cocktail as a precautionary measure. The president then had said the experimental drug helped him recover.

Regeneron added that it continues to advance clinical trial programs evaluating REGEN-COV2 for both the treatment and prevention of COVID-19.

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