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.
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