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
- “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.