Shots:

• The approval was based on the P-III (PINETREE) trial to evaluate the efficacy and safety of Veklury (IV) vs PBO in a ratio (1:1) in 562 non-hospitalized patients with COVID-19 who are at high risk for disease progression
• The results showed an 87% reduction in risk for the composite 1EPs of COVID-19 related hospitalization or all-cause death by Day 28 (0.7% [2/279]) vs (5.3% [15/283]), no deaths were observed & the safety profile was similar b/w Veklury & PBO across the variety of outpatient settings
• The US FDA has also expanded the EUA of Veklury to include non-hospitalized pediatric patients aged ≤12yrs. who are at high risk of disease progression

Ref: Gilead | Image: Gilead