The US Food and Drug Administration on Saturday issued an emergency use authorization for Regeneron's antibody cocktail to treat Covid-19 in high-risk patients with mild to moderate disease.
President Donald Trump received the therapy, called REGEN-COV2, when he was hospitalized for coronavirus. The treatment has to be infused into the bloodstream and is meant to mimic an immune response to infection.
The cocktail reduced Covid-19-related hospitalizations and emergency room visits in some patients within 28 days of treatment, the FDA said in a news release.
Regeneron's chief executive officer, Dr. Leonard S. Schleifer, said in a statement that demand may initially exceed supply, "making it even more critical that federal and state governments ensure REGEN-COV2 is distributed fairly and equitably to the patients most in need."
Some context: An emergency use authorization (EUA) is a lower regulatory bar than full approval by the FDA. An EUA allows products to be used under particular circumstances before all the evidence is available for approval.
"When used to treat Covid-19 for the authorized population, the known and potential benefits of these antibodies outweigh the known and potential risks," the FDA said.
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