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FDA Expands Use of Remdesivir to Adult And Pediatric Patients With High Risk of Hospitalization

On Jan. 21, the U.S. Food and Drug Administration took two actions to expand the use of Gilead’s antiviral drug Veklury (remdesivir) to certain non-hospitalized adults and pediatric patients for the treatment of mild-to-moderate COVID-19 disease.

Previously, the use of Veklury was limited to patients requiring hospitalization.

The FDA expanded the approved indication for Veklury to include its use in adults and pediatric patients (12 years of age and older who weigh at least 40 kilograms) who are not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19.

The agency also revised the EUA for Veklury to additionally authorize it for treatment of pediatric patients weighing 3.5 to 40 kilograms, or patients less than 12 years of age weighing at least 3.5 kilograms, who are not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19.

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, and pediatric patients fowill receive doses adjusted for their body weight to achieve comparable exposures to adults and pediatric patients receiving the approved dose.

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