Press Release: REGENERON – FDA Authorizes Lower 1,200 MG Intravenous and Subcutaneous Dose of REGEN-COV™ (Casirivimab and Imdevimab) Antibody Cocktail To Treat Patients With COVID-19
TARRYTOWN, N.Y., June 4, 2021 /PRNewswire/ —
EUA supported by pivotal Phase 3 data showing 1,200 mg dose reduced risk of hospitalization or death by 70%
Only antibody therapy currently available in all 50 states, including eight states with high rates of two variants of concern
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) updated the Emergency Use Authorization (EUA) for REGEN-COV™, lowering the dose to 1,200 mg (600 mg casirivimab and 600 mg imdevimab), which is half the dose originally authorized. As part of the updated EUA, REGEN-COV should be administered by intravenous (IV) infusion; subcutaneous (SC) injections are an alternative when IV infusion is not feasible and would lead to a delay in treatment.
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