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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

Updated 36 mins ago - Politics & Policy

Coronavirus dashboard

Illustration: Sarah Grillo/Axios

  1. Health: Coronavirus may have been in U.S. in December 2019, study finds — Hospital crisis deepens as holiday season nears.
  2. Politics: Bipartisan group of senators unveil $908 billion COVID stimulus proposalFDA chief was called to West Wing to explain why agency hasn't moved faster on vaccine — The words that actually persuade people on the pandemic
  3. Vaccine: Moderna to file for FDA emergency use authorizationVaccinating rural America won't be easy — Being last in the vaccine queue is young people's next big COVID test.
  4. States: Cuomo orders emergency hospital protocols as New York's COVID capacity dwindles.
  5. World: European regulators to assess first COVID-19 vaccine by Dec. 29
  6. 🎧 Podcast: The state of play of the top vaccines.
Nov 30, 2020 - Health

Young people's next big COVID test

Illustration: Eniola Odetunde/Axios

Young, healthy people will be at the back of the line for coronavirus vaccines, and they'll have to maintain their sense of urgency as they wait their turn — otherwise, vaccinations won't be as effective in bringing the pandemic to a close.

The big picture: "It’s great young people are anticipating the vaccine," said Jewel Mullen, associate dean for health equity at Dell Medical School at the University of Texas at Austin. But the prospect of that enthusiasm waning is "a cause for concern," she said.

Chuck Grassley returns to Senate after recovering from COVID-19

Photo: Sarah Silbiger/Getty Images

Sen. Chuck Grassley (R-Iowa) returned to in-person work on Monday after quarantining with an asymptomatic case of the coronavirus, his office said in a statement.

Why it matters: Grassley, 87, is the second oldest member of the Senate, meaning he was at high risk for a severe infection. But the senator reports that he remained asymptomatic the entire time he was in quarantine.