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FDA OKS EMERGENCY USE AUTHORIZATION FOR DRUG GIVEN TO TRUMP

The Food and Drug Administration has granted emergency authorization for the experimental antibody treatment given to President Trump shortly after he was diagnosed with COVID-19, giving doctors another option to treat COVID-19 patients as cases across the country continue to rise, Katie Thomas and Noah Weiland reported for the New York Times.

The treatment, made by the biotech company Regeneron, is a cocktail of two powerful antibodies that have shown promise in early studies at keeping the infection in check, reducing medical visits in patients who get the drug early in the course of their disease. A similar treatment, made by Eli Lilly, was given emergency approval earlier this month.


The emergency authorization for Regeneron’s drug is limited in scope: It is for people who have tested positive for the coronavirus and who are at high risk for developing severe COVID-19. Evidence so far suggests that antibody treatments work best early in the course of the disease, before the virus has gained a foothold in the body. Like Eli Lilly’s treatment, Regeneron’s is not authorized for use in people who are hospitalized or who need oxygen.


The emergency authorization raises immediate questions about who will get access to the treatments as an average of more than 168,000 people are diagnosed each day with COVID-19 in the United States and hospitals are running out of beds in some regions of the country. Regeneron has said it will have enough of the drug for only about 80,000 people by the end of November, enough for 200,000 patients by the first week of January, and 300,000 by the end of January. After that, the company said it will be able to ramp up production thanks to a partnership with the Swiss manufacturer Roche.




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