FDA expands emergency use authorization for remdesivir to include all hospitalized COVID-19 patients

While FDA broadened the scope of its existing emergency use authorization (EUA) for remdesivir (Veklury, Gilead), a recent major study showed mixed results for the COVID-19 treatment drug.

The FDA’s EUA for remdesivir now includes treatment of all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19, regardless of the severity of the disease, the agency said in a press release.

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When FDA originally issued the EUA for remdesivir in May, the authorization was limited to patients with severe disease, defined as low blood oxygen levels, needing oxygen therapy, or more intensive breathing support, such as a mechanical ventilator.

Based on the agency’s review of all of the scientific information now available, a press release from the agency said it is “reasonable to believe Veklury may be effective for the treatment of suspected or laboratory-confirmed COVID-19 in all hospitalized adult and pediatric patients."

Gilead is working on developing an inhaled version of remdesivir. In its current formulation, the antiviral is administered intravenously.

A recent phase 3 study showed that moderately-ill patients COVID-19 patients who were on a 5-day course of remdesevir plus standard care were 65% more likely to have their condition improve compared with patients on standard care. However, for patients on a 10-day course, the chances of improvement were not statistically significant, FiercePharma reported.

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Stephen M. Hahn

The FDA, though, pointed to a randomized, double-blind, placebo-controlled clinical trial (ACTT-1), funded by the National Institute of Allergy and Infectious Diseases, that evaluated how long it took for subjects to recover from COVID-19 within 29 days of being treated. The trial included 1,062 hospitalized subjects with mild, moderate, or severe COVID-19 who received remdesivir or placebo, plus standard of care. The median time to recovery from COVID-19 was 10 days for the Veklury group compared with 15 days for the placebo group. This data and other data show that remdesivir “has the potential to help even more hospitalized patients who are suffering from the effects of this devastating virus,” said FDA Commissioner Stephen M. Hahn, M.D. “We are working with drug developers to conduct randomized clinical trials to further study the safety and effectiveness of a number of potential therapies for COVID-19.”

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