Benzinga | Jan 24, 2022 05:52AM EST

FDA Approves Gilead's Remdesivir For Non-Hospitalized COVID-19 Patients At High Risk For Disease Progression

The FDA has approved Gilead Sciences Inc's (NASDAQ:GILD) Veklury (remdesivir) for non-hospitalized adult and adolescent patients at high risk of progression to severe COVID-19.

* This approval expands the role of Veklury, which is the antiviral standard of care for treating patients hospitalized with COVID-19.

* The expanded indication allows Veklury to administer daily intravenous (IV) infusions over three consecutive days in outpatient settings.

* The FDA has also expanded the pediatric Emergency Use Authorization (EUA) of Veklury to include non-hospitalized pediatric patients younger than 12 years who are at high risk of disease progression.

* Related: European Commission Expands Use Of Remdesivir In COVID-19 Patients Not On Supplemental Oxygen.

* The expanded approval is based on the PINETREE Phase 3 d trial results.

* The trial evaluated the efficacy and safety of a three-day course of Veklury for intravenous (IV) use for non-hospitalized patients at high risk for disease progression.

* Veklury resulted in an 87% reduction in risk for the composite primary endpoint of COVID-19 related hospitalization or all-cause death by Day 28 than placebo (0.7% vs. 5.3%).

* No deaths were observed in either arm in the study by Day 28.

* Price Action: GILD shares closed at $68.51 on Friday.