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June 4, 2021Lower Dose, New Route of Administration Authorized for REGEN-COV COVID-19 Treatment
June 4, 2021 – The U.S. FDA has updated the emergency use authorization (EUA) for Regeneron’s REGEN- COVTM (casirivimab/imdevimab), a combination monoclonal antibody treatment for COVID-19. The update lowers the recommended dose of REGEN-COV by half, to 600mg casirivimab and 600mg imdevimab. It also adds an option for subcutaneous (SC) injection when the originally authorized intravenous route of administration is not feasible and would cause a delay in treatment.
REGEN-COV has been authorized since November 2020 to treat mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40kg, or 88 pounds) who have positive results of direct SARS-CoV-2 viral testing and are at high risk of progression to severe COVID-19, including hospitalization or death. This authorization does not represent full FDA approval. Rather, an EUA provides a means by which the FDA can make unapproved products available to address public health emergencies based on the current totality of scientific evidence and balance of known and potential risks against known and potential benefits.
In a clinical trial, REGEN-COV reduced the risk of hospitalization or death by 70% in high-risk non- hospitalized patients, with a consistent treatment effect observed between the newly authorized dose and the originally authorized dose (1,200mg casirivimab/1,200mg imdevimab). Authorization of the new SC injection route of administration is based on the totality of current scientific evidence, including clinical, viral load reduction, and pharmacokinetic (how a drug moves through the body) data.
The REGEN-COV 1,200mg casirivimab/1,200mg imdevimab dose is no longer authorized.