Maine CDC HAN: Expanded U.S. FDA Approval of Remdesivir for COVID-19 Treatment

Posted on January 25, 2022

On January 21, 2022, the U.S. Food and Drug Administration (FDA) granted full approval to the antiviral drug remdesivir (Veklury) to treat non-hospitalized patients 12 years of age and older with mild-to-moderate COVID-19 disease who are at high risk of hospitalization. This expanded approval provides another treatment option to reduce the risk of hospitalization in high-risk patients. The use of remdesivir was previously limited to patients requiring hospitalization, and treatment outside the hospital was off-label. Remdesivir’s manufacturer, Gilead Sciences, Inc., indicates that it has been able to meet demand for this drug. In vitro data suggest that remdesivir remains active against the Omicron variant of SARS-CoV-2.

The expanded indication allows remdesivir to be administered in qualified outpatient settings that can administer daily intravenous (IV) infusions over three consecutive days. The FDA also expanded remdesivir’s pediatric Emergency Use Authorization (EUA) to include non-hospitalized pediatric patients younger than 12 years of age (over 3.5 kg) who are at high risk of disease progression.