European Commission Expands Use Of Remdesivir In COVID-19 Patients Not On Supplemental Oxygen

The European Commission (EC) has approved a variation to the Conditional Marketing Authorization for Gilead Sciences Inc's GILD Veklury (remdesivir) to include adults who do not require supplemental oxygen and are at an increased risk of progressing to severe COVID-19. 

• This decision follows the favorable recommendation of the Committee for Medicinal Products for Human Use (CHMP).
• Results from a Phase 3 trial support the EC's decision to evaluate the efficacy and safety of a three-day course of Veklury for intravenous (IV) use to treat COVID-19 in non-hospitalized patients at high risk for disease progression. 
• Related Link: Gilead Recalls Two Lots Of Remdesivir Due To Presence Of Glass Particulates.
• In an analysis of 562 participants, Veklury demonstrated a statistically significant 87% reduction in risk for the composite primary endpoint of COVID-19 related hospitalization or all-cause death by Day 28 compared with placebo (5.3%).
• No deaths were observed in either arm in the study by Day 28. 
• This expanded indication in the EU adds to the previous conditional authorization of Veklury for COVID-19 in adults and adolescents (aged 12 to less than 18 years and weighing at least 40 kg) with pneumonia requiring supplemental oxygen.
• Price Action: GILD shares are down 0.66% at $71.99 during the market session on the last check Tuesday.