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A combination monoclonal antibody cocktail produced by Regeneron and Roche has shown to reduce hospitalization or death in COVID-19 patients by as much as 70%, a press release posted Tuesday said. The combo therapy, dubbed REGEN-COV, was being evaluated in a Phase 3 trial involving high-risk non-hospitalized COVID-19 patients.
REGEN-COV is comprised of casirivimab with imdevimab, and has already received emergency use authorization from the FDA in the U.S. Under the current EUA, the combo therapy is approved to treat non-hospitalized adults and adolescents with mild to moderate symptoms of COVID-19 and who are at high risk for developing severe symptoms or the 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 symptom onset.
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The press release, published by Regeneron Pharmaceuticals, Inc., also noted that the therapy reduced symptom duration and that a companion Phase 2 trial saw reduced viral load reductions in patients given low doses of REGEN-COV. The trial saw patients given 300 mg intravenously and 600 mg subcutaneously, with researchers noting reductions over the first seven days comparable to those given the 2,400 mg and 1,200 mg intravenous doses.
REGEN-COV is comprised of casirivimab with imdevimab, and has already received emergency use authorization from the FDA in the U.S.
“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, health care providers and others to support rapid and widespread adoption of REGEN-COV in appropriate patients,” George D. Yancopoulos, M.D., Ph.D., Regeneron’s president and chief scientific officer, said in the press release. “We will rapidly discuss the new data with regulatory authorities and request that the 1,200 mg dose be added to the U.S. Emergency Use Authorization, in order for the anticipated REGEN-COV supply to be available to treat even more patients.”
The company said there are ongoing trials involving REGEN-COV including one in the U.K. studying the impact it may have on hospitalized patients. Another is evaluating the prevention of COVID-19 in household contacts of infected individuals.
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