FDA Expands Emergency Use of Gilead’s Remdesivir for COVID-19

FDA is expanding its Emergency Use Authorization (EUA) of Gilead’s remdesivir (Veklury) to certain non-hospitalized adults and pediatric COVID-19 patients.

Previously, Veklury was limited to patients requiring hospitalization.

“On the heels of the FDA’s recent authorization of two oral antiviral drugs, today’s actions (Jan. 21) bolster the arsenal of therapeutics to treat COVID-19 and respond to the surge of the omicron variant,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, in a news release.

“Today’s actions provide adults and pediatric patients, with mild-to-moderate COVID-19 who are at high risk of severe COVID-19 with a treatment option they could receive outside of a traditional inpatient hospital setting, including at skilled nursing facilities, home healthcare settings and outpatient facilities such as infusion centers,” Cavazonni added.

The EUA applies to patients with positive results of direct SARS-CoV-2 viral testing who are not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.

The agency also revised Veklury’s EUA to authorize the drug for treatment of pediatric patients weighing 3.5 kilograms to less than 40 kilograms, or pediatric patients less than 12 years of age weighing at least 3.5 kilograms with positive results of direct SARS-CoV-2 viral testing, who are not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization of death.

The high-risk non-hospitalized patients may receive Veklury via intravenous infusion for 3 days for the treatment of mild-to-moderate COVID-19 disease.

The approval of Veklury for use in non-hospitalized patients is supported by a randomized, placebo-controlled clinical trial that included 562 non-hospitalized patients with mild-to-moderate COVID-19 who were at high risk for progression to severe COVID-19, including hospitalization or death.

Overall, 0.7% of patients who received Veklury required COVID-19-related hospitalization compared to 5.3% who received a placebo.

There were no deaths in either group.

In August 2020, the FDA expanded the EUA for remdesivir to include 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.