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The FDA approves acute use of Regeneron COVID treatment that Trump received



The Food and Drug Administration announced Saturday night that it has authorized emergency use of Regeneron Pharmaceuticals’ antibody cocktail, which was given to President Trump to treat his COVID-19 infection last month.

Why it matters: Regeneron’s two monoclonal antibodies, casirivimab and imdevimab, are for people who tested positive for coronavirus and “who are at high risk of developing severe COVID-19”, including people 65 and older and / or people with certain chronic diseases, according to an FDA statement.

Note: “The safety and efficacy of this study treatment for use in the treatment of COVID-1

9 are still being evaluated,” the FDA said.

  • “Casirivimab and imdevimab are not approved for patients who are hospitalized due to COVID-19 or need oxygen therapy due to COVID-19.”

Running the news: A clinical trial in patients with COVID-19 showed that when the two antibodies were co-administered, “it was found that they reduced COVID-19-related hospitalization or emergency visits in patients at high risk of disease progression within 28 days of treatment compared to placebo, ”said the FDA.

  • Regeneron’s President and Chief Scientific Officer George Yancopoulos said in a statement that this trial of about 800 inpatients “showed significant reductions in virus levels within a few days” after receiving the treatment, called REGEN-COV2, “which was linked. with significantly fewer medical visits. “

What to expect: Regeneron expects to have doses of REGEN-COV2 ready for approx. 80,000 patients before the end of November, approx. 200,000 patients before the first week of January and approx. 300,000 patients in total by the end of January 2021.

For the record: The FDA issued a similar emergency drug approval for Eli Lilly’s antibody treatment, bamlanivimab, earlier this month.

Go deeper: Regeneron CEO: Trump’s success with antibody cocktails is not a sign of cure

Editor’s note: This article has been updated with new details throughout.


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