FDA broadens EUA for COVID-19 treatment

Sept. 1, 2020

The U.S. Food and Drug Administration (FDA) broadened the scope of an existing emergency use authorization (EUA) for the drug Veklury (remdesivir) to include treatment of all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19, irrespective of their severity of disease, the agency said in a press release.

The new action follows the FDA’s decision in May to issue an EUA that authorized Veklury for the treatment of hospitalized adult and pediatric patients with severe COVID-19, which was defined as patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator.

The FDA said the revised EUA was based on “a review of the totality of scientific information now available,” and it cited two studies included in that process.

The first was a randomized, double-blind, placebo-controlled clinical trial (ACTT-1), conducted by the National Institute of Allergy and Infectious Diseases (NIAID), evaluated how long it took for subjects to recover from COVID-19. The trial looked at 1,062 hospitalized subjects with mild, moderate and severe COVID-19 who received Veklury or placebo plus standard care. The median time to recovery from COVID-19 was 10 days for the Veklury group, compared to 15 days for the placebo group, a statistically significant difference.

The second was a randomized, open-label multi-center clinical trial of hospitalized adult subjects with moderate COVID-19. The study compared treatment with Veklury for five days and treatment with Veklury for 10 days with standard care. Overall, the odds of a subject’s COVID-19 symptoms improving were statistically significantly higher in the five-day Veklury group at Day 11 when compared to those receiving only standard care. The odds of improvement with the 10-day treatment group when compared to those receiving only standard care were numerically favorable, but not statistically significant. At Day 28, mortality was less than or equal to 2 percent in all treatment groups,

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