The European Commission (EC) has approved a variation to the Conditional Marketing Authorization for Gilead Sciences Inc's (NASDAQ: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.
