The U.S. Food and Drug Administration has expanded the use of the antiviral drug Veklury (remdesivir) to certain non-hospitalized adults and paediatric patients for the treatment of mild-to-moderate Covid-19 disease. This 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.

"On the heels of the FDA's recent authorization of two oral antiviral drugs, today's actions 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. "Today's actions provide adults and paediatric 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."

The FDA has expanded the approved indication for Veklury to include its use in adults and paediatric patients (12 years of age and older who weigh at least 40 kilograms, which is about 88 pounds) with positive results of direct SARS-CoV-2 viral testing, and 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.

Based on today's actions, these high-risk non-hospitalized patients may receive Veklury via intravenous infusion for a total of three 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. The main outcome measured in the trial was whether a patient was hospitalized for any Covid-19 related reason or died from any reason within 28 days of treatment. Overall, 2 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.

Paediatric patients for whom Veklury is authorized will receive doses adjusted for their body weight in order to achieve comparable exposures to adults and paediatric patients receiving the approved dose. Given the similar course of Covid-19 disease, the authorization of Veklury in certain paediatric patients is based on extrapolation of efficacy from adequate and well-controlled studies in adults.