A combined monoclonal antibody cocktail produced by Regeneron and Roche has been shown to reduce hospitalization or death in patients with COVID-19 by up to 70%, a press release published on Tuesday said. The combination therapy, dubbed REGEN-COV, was being evaluated in a Phase 3 study involving out-of-hospital high-risk COVID-19 patients.
REGEN-COV is composed of casirivimab with imdevimab and has already received emergency use authorization from the FDA in the United States. Under the current USA, combination therapy is approved to treat adults and adolescents who are not hospitalized with mild to moderate symptoms of COVID-19 and who are at high risk of developing severe symptoms or need for hospitalization.
The currently authorized dosage is 1,200 mg of casirivimab and 1,200 mg of imdevimab, administered together as a single infusion within 10 days of the onset of symptoms.
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The press release, published by Regeneron Pharmaceuticals, Inc., also noted that the therapy reduced the duration of symptoms and that a Phase 2 study followed reductions in viral load in patients who received low doses of REGEN-COV. The study saw patients receiving 300 mg intravenously and 600 mg subcutaneously, with the researchers seeing reductions over the first seven days comparable to those receiving doses of 2,400 mg and 1,200 mg intravenously.
REGEN-COV is composed of casirivimab with imdevimab and has already received emergency use authorization from the FDA in the USA
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“With approximately 60,000 newly diagnosed individuals in the U.S. every day and 40,000 still in the hospital because of COVID-19, we are committed to working with the government, healthcare providers and others to support the rapid and widespread adoption of REGEN- VOCs appropriately patients, “said George D. Yancopoulos, MD, Ph.D., president and chief scientific officer of Regeneron, in the press release. “We will quickly discuss the new data with regulatory authorities and will request that the 1,200 mg dose be added to the United States Emergency Use Authorization, so that the anticipated supply of REGEN-COV is available to treat even more patients.”
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The company said there are ongoing studies involving REGEN-COV, including one in the UK that studies the impact it can have on hospitalized patients. Another is to evaluate the prevention of COVID-19 in household contacts of infected individuals.