Gilead Sciences, Inc. (GILD) announced Wednesday positive results from a Phase 3 randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of a three-day course of Veklury (remdesivir) for intravenous (IV) use for the treatment of COVID-19 in non-hospitalized patients at high risk for disease progression. This late-breaking data will be presented at the IDWeek 2021 virtual conference.<\/p>\n
In an analysis of 562 participants randomly assigned in a 1:1 ratio to receive Veklury or placebo, 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.<\/p>\n
The results also showed an 81% reduction in risk for the composite secondary endpoint of medical visits due to COVID-19 or all-cause death by Day 28 for participants treated with Veklury, compared with placebo. In the study, no deaths were observed in either arm by Day 28.<\/p>\n
These results complement positive results from ACTT-1 and other studies in hospitalized patients in which Veklury helped patients recover significantly faster and reduced the likelihood of disease progression.<\/p>\n
The use of Veklury for the treatment of non-hospitalized patients with three days of dosing is investigational, and the safety and efficacy for this use and dosing duration have not been established or approved by any regulatory agency globally.<\/p>\n
In the U.S., Veklury is indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization.<\/p>\n
Gilead is also developing novel oral treatment options for non-hospitalized patients with COVID-19 and hopes to file investigational new drug applications (IND) with the U.S. Food and Drug Administration (FDA) by early next year. <\/p>\n