Remdesivir

The FDA approved an emergency use authorization (EUA) for remdesivir, an investigational antiviral agent, to treat patients hospitalized with severe COVID-19, the agency said Friday, May 1.

Authorization was granted on the basis of two clinical trials, including results from a randomized trial of remdesivir released by the National Institute of Allergy and Infectious Diseases in a press release this week. Interim analyses of the trial showed the drug met its primary endpoint, a 31% significantly faster time to recovery over controls.

The FDA defined "severe" disease as "patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator."

The other trial was a phase III trial conducted by the drug manufacturer, Gilead Sciences, which found no significant difference in clinical improvement with a 5-day versus a 10-day course of the drug, the agency said in a letter to the drugmaker.

"I think this really illustrates what can happen in such a short time. For the first case, that was diagnosed in the United States to now, our first step forward with a therapeutic in less than 90 days," said Ambassador-at-Large Deborah Birx, MD, on the drug, according to White House pool reports.

Department of Health and Human Services Secretary Alex Azar said the EUA is "another example of the Trump Administration moving as quickly as possible to use science to save lives" in a statement released by the FDA.

Both 5-day and 10-day treatment durations will be considered, based on the severity of disease, Gilead said in a release. The company added that the U.S. government will help to distribute remdesivir to hospitals in cities most heavily affected by the COVID-19 outbreak, adding "hospitals with intensive care units and other hospitals that the government deems most in need" will be prioritized, in part due to limited availability of drug supply.

Remdesivir requires intravenous administration, and both optimal dosing and treatment duration for COVID-19 is still unknown, the manufacturer said. However, the company said that under the EUA, a 10-day dosing duration will be recommended for patients requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO). For a patient on a 5-day course, if clinical improvement is not demonstrated within 5 days, treatment may be extended an additional 5 days, the manufacturer said.

Potential side effects of the drug include increased levels of liver enzymes and infusion-related reactions, the agency noted.

Gilead said multiple clinical trials to test remdesivir's safety and efficacy are still ongoing, including a randomized phase III trial in patients with less severe illness, which includes a usual-care control group.

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