FDA Updates EUA For REGEN-COV With Lower Dosage Of 1,200 Mg – Quick Facts
Regeneron Pharmaceuticals, Inc. (REGN) announced Friday that 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, with subcutaneous (SC) injections being an alternative when IV infusion is not feasible and would lead to a delay in treatment.
REGEN-COV is authorized for use under an EUA to treat mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing =40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
The updated FDA authorization is based on data from several trials, including a recently presented Phase 3 trial which showed REGEN-COV reduced the risk of hospitalization or death by 70% in high-risk non-hospitalized patients, and that the treatment effect was consistent between the 1,200 mg and 2,400 mg doses.
In addition, in vitro research has shown that REGEN-COV retains potency against the main variants of concern circulating within the U.S., including the P.1 variant (first identified in Brazil, now classified by the World Health Organization [WHO] as Gamma) and the B.1.351 variant (first identified in South Africa.
Consequently, REGEN-COV remains available for use in all 50 states. The combined frequency of the P.1 and B.1.351 variants now exceeds 10% of new COVID-19 diagnoses across eight states and the prevalence of these and other variants continues to be closely monitored.
Regeneron expects to submit a full Biologics License Application (BLA) for REGEN-COV in non-hospitalized outpatients with COVID-19 later this summer. In addition to outpatients, REGEN-COV is also being evaluated in prevention and certain hospitalized COVID-19 patient settings.
The U.S. government will purchase all REGEN-COV doses delivered by June 30, 2021 and may accept additional doses through September 30, 2021 at its discretion, up to a maximum amount of 1.25 million doses. Regeneron expects to deliver at least 1 million REGEN-COV doses to the U.S. government in the second quarter. Regeneron is collaborating with Roche to increase global supply of REGEN-COV.
REGEN-COV (casirivimab and imdevimab) is a cocktail of two monoclonal antibodies (also known as REGN10933 and REGN10987) that was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19, using Regeneron’s proprietary VelocImmune® and VelociSuite technologies.
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