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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 Mar 2, 2021 - Politics & Policy

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Illustration: Aïda Amer/Axios

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  2. Axios-Ipsos poll: Americans' hopes rise after a year of COVID
  3. Vaccine: J&J CEO "absolutely" confident in vaccine distribution goals — Vaccine hesitancy is shrinking.
  4. World: China and Russia vaccinate the world, for now.
  5. Energy: Global carbon emissions rebound to pre-COVID levels.
  6. Local: Florida gets more good vaccine newsMinnesota's hunger problem grows amid pandemic — Denver's fitness industry eyes a pandemic recovery.
Jan 29, 2021 - World

EU grants conditional approval of AstraZeneca vaccine

Photo: Sunil Ghosh/Hindustan Times via Getty Images

The European Commission on Friday granted conditional approval of the Oxford-AstraZeneca coronavirus vaccine for people 18 years and older.

Why it matters: This is the third vaccine to receive approval from the commission, coming hours after the Emergency Medicines Agency recommended its authorization.

Jan 30, 2021 - World

Science helps New Zealand avoid another coronavirus lockdown

New Zealand Prime Minister Jacinda Ardern (L) visits a lab at Auckland University in December. Photo: Phil Walter/Getty Images

New Zealand has avoided locking down for a second time over COVID-19 community cases because of a swift, science-led response.

Why it matters: The Health Ministry said in an email to Axios Friday there's "no evidence of community transmission" despite three people testing positive after leaving managed hotel isolation. That means Kiwis can continue to visit bars, restaurants and events as much of the world remains on lockdown.