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The US Food and Drug Administration (FDA) on Friday expanded its emergency use authorization (EUA) of remdesivir (Veklury) to include treatment of all adult and pediatric hospitalized COVID-19 patients, regardless of the severity of their disease.
An EUA of remdesivir issued in May allowed the drug to be used only for patients with severe COVID-19, specifically, COVID-19 patients with low blood oxygen levels or who need oxygen therapy or mechanical ventilation.
"Today, based on the Agency's ongoing review of the EUA, including its review of the totality of scientific information now available, the FDA has determined that 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," the FDA news release about the expanded EUA said. "The Agency's review has also concluded that the known and potential benefits of Veklury outweigh the known and potential risks for these uses."
"Further Evaluation" Needed
The EUA expansion is partially based on the results of a randomized, open-label trial that Gilead Sciences, remdesivir's manufacturer, conducted at multiple sites.
The trial showed that a 5-day course of remdesivir was associated with statistically significant improvement among patients hospitalized with moderate COVID-19 in comparison with standard care.
However, patients who were randomly assigned to a receive longer, 10-day remdesivir course had not improved significantly 11 days after treatment started, compared with those who received standard care.
Results with remdesivir in this trial and in two previously reported randomized trials varied, "raising the question of whether the discrepancies are artifacts of study design choices, including patient populations, or whether the drug is less efficacious than hoped," wrote Erin K. McCreary, PharmD, and Derek C. Angus, MD, MPH, with the University of Pittsburgh School of Medicine in Pennsylvania, in an editorial that accompanied publication of the trials in JAMA.
Angus previously expressed concern that expanding remdesivir's EUA could "interrupt or thwart efforts to execute the needed RCTs [randomized controlled trials].
"We think there really needs to be further evaluation of remdesivir in large-scale RCTs adequately powered to understand in which patients, at which dose, given at which point in the course of illness leads to what concrete and tangible improvement in clinical outcomes," he told Medscape Medical News.
"At this point, remdesivir definitely holds promise, but given the cost to produce and distribute the drug, it seems crucial to know with more certainty how best to use it," Angus said.
The EUA expansion is also partially based on results from a randomized, double-blind, placebo-controlled clinical trial that the National Institutes of Allergy and Infectious Diseases conducted. In that trial, there was a statistically significant reduction in median recovery time and higher odds of clinical improvement after 2 weeks for hospitalized patients who received remdesivir.
For hospitalized patients with mild to moderate disease, the results were consistent with the overall study results but were not statistically significant.
Ellie Kincaid is Medscape's associate managing editor. She has previously written about healthcare for Forbes, the Wall Street Journal, and Nature Medicine. She can be reached by email at ekincaid@medscape.net and on Twitter @ellie_kincaid.
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