FDA expands use of remdesivir in patients with COVID-19
The FDA recently announced it has expanded its approval of Gilead Sciences’ antiviral drug remdesivir — marketed in the U.S. as Veklury — to allow certain outpatients with COVID-19 to receive it.
According to a press release, the FDA expanded the approval of IV remdesivir to include nonhospitalized adults and children aged 12 years and older weighing at least 40 kg (about 88 lbs.) who have mild to moderate COVID-19 and are at high risk for advancement to severe disease, including hospitalization or death.
The FDA said it also updated its emergency use authorization for remdesivir to include children who weigh 3.5 kg to less than 40 kg or children aged less than 12 years who weigh at least 3.5 kg and have tested positive for SARS-CoV-2 via viral testing, are not hospitalized, have mild to moderate disease and are at high risk for progression to severe COVID-19, including hospitalization or death.
Both FDA decisions allow remdesivir to be administered to nonhospitalized, high-risk patients for a total of 3 days, the agency said. Children who are prescribed the drug should receive a weight-adjusted dose, according to the press release.
The expanded approval of remdesivir is based on a randomized controlled trial of 562 nonhospitalized patients with mild to moderate COVID-19 who were at elevated risk for progression to severe disease. Of the 279 patients who received remdesivir, two were hospitalized for COVID-19 compared with 15 of the 283 patients who received placebo (0.7% vs. 5.3%), according to the FDA. No deaths occurred in either group. As Healio previously reported, the trial also showed that an early 3-day course of remdesivir lowered the risk for hospitalization or death by 87%.
The FDA’s “actions bolster the arsenal of therapeutics to treat COVID-19 and respond to the surge of the omicron variant,” Patrizia Cavazzoni, MD, the director of the FDA’s Center for Drug Evaluation and Research, said in the press release. The actions also offer a therapeutic option “outside of a traditional inpatient hospital setting, including at skilled nursing facilities, home health care settings and outpatient facilities such as infusion centers,” she said.
Remdesivir use was previously restricted to patients requiring hospitalization from the disease.