FDA Approves Lower Dose of Regeneron’s COVID-19 Antibody Cocktail

June 7, 2021

Regeneron Pharmaceuticals has received an updated Emergency Use Authorization (EUA) from the FDA for a lower dosage of its COVID-19 antibody cocktail, REGEN-COV (casirivimab/imdevimab).

The FDA has authorized a 1,200-mg dose, which is half of the amount originally authorized (DID, Nov. 24, 2020). The revised EUA also says REGEN-COV should be delivered by intravenous (IV) infusion but that subcutaneous injections are an acceptable alternative if an IV infusion isn’t feasible or would cause a treatment delay.

The updated EUA was supported by data from several trials, including results from a phase 3 study demonstrating REGEN-COVD cut the risk of hospitalization or death by 70 percent in high-risk nonhospitalized patients, with a treatment effect “consistent” across both the 1,200-mg and 2,400-mg doses.

The new subcutaneous administration was supported by the “totality of scientific evidence,” which includes clinical, viral load reduction and pharmacokinetic data, the company said.

According to Regeneron, the antibody cocktail also offers protection against several SARS‑CoV‑2 variants circulating in the U.S., such as the variants first identified in Brazil and in South Africa.

The company plans to submit a Biologics License Application for REGEN-COV covering nonhospitalized COVID-19 patients later this summer. ― Jason Scott