Regeneron’s Coronavirus Treatment Becomes First Antibody Cocktail to Earn Emergency Use Authorization from FDA

There’s a new coronavirus treatment option that will go a long way to prevent hospitals from getting swarmed with severe patients this winter. On Saturday night, Regeneron‘s (NASDAQ:REGN) COVID-19 treatment candidate, REGEN-COV2, earned emergency use authorization (EUA) from the FDA to treat recently diagnosed patients at high risk of becoming severely affected.

The first COVID-19 antibody cocktail

On Nov. 9, the FDA authorized bamlanivimab, an antibody treatment from Eli Lilly (NYSE:LLY) for the same group of patients. Lilly’s also working on a cocktail of its own that combines bamlanivimab and LY-CoV016. Both seek out and stick to spike proteins on the surface of SARS-CoV-2, the virus responsible for COVID-19.

Gloved hands preparing an injection.

Image source: Getty Images.

Regeneron committed to a combined antibody approach early and it looks like a smart move. Clinical trial participants randomized to receive treatment with REGEN-COV2 were 57% less likely to report a COVID-19 related medical visit than patients given a placebo. Among COVID-19 patients with one or more risk factors that makes them likely to develop severe symptoms, treatment with REGEN-COV2 led to an even more impressive 72% risk reduction.

Regeneron expects to have doses for around 80,000 patients ready by the end of November. With help in the manufacturing and distribution department from Roche (OTC:RHHBY), one of the world’s largest drugmakers, Regeneron thinks doses for around 300,000 patients will be ready by the end of January 2021. 

Part of Regeneron’s Operation Warp Speed deal included an agreement to supply the U.S. government with 300,000 doses of REGEN-COV2. The government has also committed to providing these doses at no cost to patients.

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