The new action provides another treatment option to reduce the risk of hospitalization in high-risk patients. Previously, the use of Veklury was limited to patients requiring hospitalization. The expanded approved indication for Veklury now includes use in adults and pediatric patients who are 12 years of age and older and weigh at least 40 kg (approximately 88 lbs), have positive results of direct SARS-CoV-2 viral testing, are not hospitalized, 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 the emergency use authorization to authorize the drug for the treatment of pediatric patients weighing 3.5 kg (7.7 lbs) to less than 40 kg or pediatric patients less than 12 years of age weighing at least 3.5 kg, 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 and death.

Based on these actions, high-risk nonhospitalized patients may receive Veklury via intravenous infusion for a total of three days.

The approval of Veklury for use in nonhospitalized patients is supported by a randomized, placebo-controlled clinical trial that included 562 nonhospitalized patients with mild-to-moderate COVID-19 who were at high risk for progression to severe COVID-19, including hospitalization or death. The main outcome measured in the trial was whether a patient was hospitalized for any COVID-19-related reason or who died from any reason within 28 days of treatment. Overall, two of 279 patients who received Veklury (0.7%) required COVID-19-related hospitalization compared to 15 of 283 patients who received a placebo (5.3%). There were no deaths in either group.

Pediatric patients for whom Veklury is authorized will receive doses adjusted for their body weight to achieve comparable exposures to adults and pediatric patients receiving the approved dose, according to the agency.