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The corporate and research and development headquarters of Regeneron Pharmaceuticals, Inc. in Tarrytown, N.Y. Photo: Lev Radin/Pacific Press/LightRocket via Getty Images


The Food and Drug Administration announced Saturday evening it has granted emergency use authorization for Regeneron Pharmaceuticals' antibody cocktail 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 the coronavirus and "who are at high risk for progressing to severe COVID-19" — including people who are 65 and older, and/or people with certain chronic illnesses, per an FDA statement.

Of note: "The safety and effectiveness of this investigational therapy for use in the treatment of COVID-19 continues to be evaluated," the FDA said.

  • "Casirivimab and imdevimab are not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19."

Driving the news: A clinical trial of coronavirus patients found that when the two antibodies were administered together, they "were shown to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo," the FDA said.

  • Regeneron president and chief scientific officer George Yancopoulos said in a statement this trial of roughly 800 non-hospitalized patients "showed significant reductions in virus levels within days" of receiving the treatment, called REGEN-COV2, "which were associated with significantly fewer medical visits."

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

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

Go deeper: Regeneron CEO: Trump's success with antibody cocktail is not evidence of cure

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

Go deeper

20 hours ago - Health

Fauci: U.S. could have herd immunity by the end of summer 2021

National Institute of Allergy and Infectious Diseases director Anthony Fauci at the White House in November. Photo: Tasos Katopodis/Getty Images

NIAID director Anthony Fauci said Tuesday the U.S. could achieve herd immunity to COVID-19 by the end of next summer or fall if there's a "good uptake" of Americans vaccinating against the virus.

Driving the news: Fauci said during an online video conversation with Colorado Gov. Jared Polis (D) he expects the general population to have access to the vaccines U.S regulators are now considering by April.

The pandemic is causing an unprecedented drop in health spending

Expand chart
Reproduced from Peterson-KFF Health System Tracker; Chart: Axios Visuals

The coronavirus pandemic has caused national health care spending to go down this year — the first time that’s ever happened.

The big picture: Any big recession depresses the use of health services because people have less money to spend. But this pandemic has also directly attacked the health system, causing people to defer or skip care for fear of becoming infected.

12 hours ago - World

Putin says Russia will begin large-scale COVID-19 vaccination next week

Photo: Sean Gallup/Getty Images

Russian President Vladimir Putin said Wednesday that he has directed officials to begin large-scale vaccination against COVID-19 as early as next week, according to state media.

Why it matters: Russia, which has the fourth-largest coronavirus caseload in the world with more than 2.3 million infections, would be the first country to begin mass vaccination. Experts have criticized the lack of scientific transparency around the vaccine and the haste with which the Kremlin approved it.