The FDA on Oct. 22 granted approval to remdesivir, which Gilead sells under the brand name Veklury, as a COVID-19 treatment for hospitalized patients aged 12 years and older.
The drug, which the FDA says can only be administered to patients who are hospitalized and weigh 88 pounds or more, is the first to receive approval from the agency to treat COVID-19.
The decision was based on the FDA’s analysis of data from three randomized, controlled clinical trials conducted on hospitalized patients with mild to severe COVID-19.
The most extensive of the trials, which was conducted by the National Institute of Allergy and Infectious Diseases, evaluated recovery times for hospitalized COVID-19 patients when given either remdesivir or a placebo. The median recovery time for patients in the remdesivir group was 10 days, compared to 15 days for the placebo group.
“Today’s approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic,” FDA Commissioner Stephen Hahn, MD, said in a statement.
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