Regeneron's COVID Treatment Gets Emergency FDA Approval

The U.S. Food and Drug Administration has issued emergency use authorization for Regeneron Pharmaceuticals Inc's REGN COVID-19 antibody cocktail.

Why It Matters: The two antibodies in the treatment, casirivimab and imdevimab, were shown to reduce COVID-19-related hospital trips within 28 days of treatment, the FDA said. It is the same antibody cocktail that U.S. President Donald Trump used when he contracted COVID-19.

The authorization is for people who test positive for COVID-19 and who are at high risk of progressing to a severe case. It covers people age 65 or older or who have certain chronic medical conditions, but it does not cover patients who are hospitalized or require oxygen therapy due to COVID-19.

What Happens Next: Regeneron expects to have 80,000 doses of the treatment, called REGEN-COV2, ready by the end of November, with more to come by the first week of January, Reuters reported.

Regeneron shares closed $518.74 on Friday, a gain of $4.03, prior to Saturday night's announcement from the FDA.

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Posted In: BiotechGovernmentNewsRegulationsFDAGeneralCOVIDReuters
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