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The FDA has approved the emergency use of Regeneron COVID treatment that Trump received



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

Why it matters: Regeneron’s two monoclonal antibodies, kazirivimab and imdevimab, are for people who test positive for coronavirus and “who are at high risk of progression to severe COVID-19”, including people aged 65 and over and / or people with certain chronic conditions. , for a statement from the FDA.

To note: “The safety and efficacy of this research therapy for use in the treatment of COVID-1

9 continues to be evaluated,” the FDA said.

  • “Kazirivimab and imdevimab are not permitted for patients who are hospitalized for COVID-19 or require oxygen therapy for COVID-19.”

News drive: A clinical trial of patients with COVID-19 found that when the two antibodies were co-administered, it was “shown to reduce COVID-19-related hospitalizations or emergency room visits in patients at high risk of disease progression within 28 days. after treatment compared to placebo, “the FDA said.

  • Regeneron President and Chief Research Officer George Jankopoulos said in a statement that this study of about 800 non-hospitalized patients “showed a significant reduction in virus levels within days” of receiving a treatment called REGEN-COV2, “which is associated with significantly fewer medical visits. “

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

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

Go deeper: Regeneron CEO: Trump’s success with antibody cocktail is not proof of cure

Editor’s note: This article is updated with new details all the time.


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