FDA Expands IV Antiviral Treatment for COVID-19 Adult and Pediatric Outpatients

The U.S. Food and Drug Administration (FDA) announced two actions on January 21, 2022, to expand the use of the antiviral drug Veklury (remdesivir) to certain non-hospitalized adults and pediatric patients for the treatment of mild-to-moderate COVID-19 disease.

Previously, the Emergency Use Authorization (EUA) of Veklury was limited to patients requiring hospitalization.

The FDA's approval of Veklury for use in non-hospitalized patients is supported by a randomized, placebo-controlled phase 3 clinical trial that included 562 non-hospitalized patients.

The primary 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%). And there were no deaths in either group. 

Furthermore, the authorization of Veklury in certain pediatric patients is based on the extrapolation of efficacy from adult clinical studies.

The agency also revised the EUA for Veklury to additionally authorize the antiviral for the 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, 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. 

Pediatric patients for whom Veklury is authorized will receive doses adjusted for their body weight.

Patrizia Cavazzoni, M.D., director of the FDA's Center for Drug Evaluation and Research, stated in a press 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." 

Based on today's FDA 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 FDA granted approval and reissued the Veklury antiviral EUA to Gilead Sciences Inc.

Note: COVID-19 antiviral treatments differ from anti-SARS-CoV-2 coronavirus monoclonal antibodies.