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 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.