The U.S. Food and Drug Administration on Saturday granted emergency authorization to the experimental antibody treatment given to President Donald Trump last month when he tested positive for the coronavirus.
The drug, made by biotech company Regeneron Pharmaceuticals, is designed to prevent infected people from developing severe illness, The Washington Post reported. The drug is a cocktail of two powerful antibodies that have demonstrated the ability to keep COVID-19 in check, The New York Times reported.
A similar treatment, made by Eli Lilly, was given emergency approval by the FDA on Nov. 9.
“This FDA Emergency Use Authorization is an important step in the fight against COVID-19, as high-risk patients in the United States will have access to a promising therapy early in the course of their infection,” Leonard S. Schleifer, President and CEO of Regeneron, said in a statement. “The science and technology investments Regeneron has made over three decades positioned us to move rapidly to invent, study and maximize production of REGEN-COV2. Even with these incredible efforts, demand may exceed supply initially, making it even more critical that federal and state governments ensure REGEN-COV2 is distributed fairly and equitably to the patients most in need. In the first quarter of 2021, we expect to increase available REGEN-COV2 global supply as we continue our collaboration with Roche.”
The FDA cleared the drug for use for treating mild to moderate COVID-19 patients for patients 12 years old and older, according to The Wall Street Journal.
The Regeneron announcement comes after vaccines made by Pfizer and Moderan were recently shown to be more than 90% effective. Pfizer submitted an application on Friday for emergency authorization. Moderna officials said they also planned to apply for a EUA, the Times reported.
Under the EUA, the recommended dose of the Regeneron antibody cocktail is 1,200 milligrams of casirivimab and 1,200 milligrams imdevimab, Regeneron said in its statement.
Trump received a dose of Regeneron’s investigational drug on Oct. 2 after he was diagnosed with COVID-19 and began showing symptoms, the Post reported. On Friday, Housing and Urban Development Secretary Ben Carson said he had also been cleared to receive the Regeneron drug for COVID-19, through Trump’s intervention, adding he was “convinced (the drug) saved my life.”
Regeneron has received more than $500 million from the federal government to develop and manufacture the treatments, the Times reported. The first 300,000 doses will be provided free of charge, but patients could be charged for having the dose administered since it must be done at a hospital or clinic.
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