Gilead Sciences Statement on Phase 3 Veklury® (Remdesivir) Intravenous Study in High Risk Non-Hospitalized Patients with COVID-19
Foster City, Calif., April 12, 2021 – Gilead has made the decision to stop its Phase 3 Veklury® (remdesivir) intravenous (IV) study in high-risk non-hospitalized patients with COVID-19. Based on the evolution of the COVID-19 landscape and challenges in enrolling this study, we no longer believe that developing a multiple day IV infusion treatment that requires administration in a healthcare setting addresses an unmet need for non-hospitalized patients. The decision to stop the study is not due to efficacy or safety concerns. Patients already enrolled in the study will continue to be followed and the study remains blinded.
While COVID-19 continues to impact many patients and their loved ones, unmet medical needs have evolved over the course of the pandemic. The primary unmet need for non-hospitalized patients with COVID-19 is for effective and convenient therapies that can be easily administered at home. Gilead remains committed to developing treatment options for non-hospitalized patients with COVID-19 that address this need. We continue to develop investigational inhaled dosage forms of remdesivir and novel oral antivirals, with the goal of delivering effective, well-tolerated and significantly more convenient treatment options for patients. We expect results from the ongoing proof-of-concept study in the remdesivir inhaled development program later this year.
Veklury remains a standard of care for the treatment of hospitalized adult patients with COVID-19. More than half of all hospitalized patients with COVID-19 in the U.S. are treated with Veklury. Gilead continues to study the efficacy and safety of Veklury in hospitalized patient populations with ongoing unmet need, such as patients with renal impairment, children and pregnant women, as well as through the support of a number of externally sponsored trials.
Veklury® (remdesivir for injection, 100 mg/vial) is FDA approved for the treatment of adults and pediatric patients at least 12 years of age and weighing at least 40 kg requiring hospitalization for COVID-19. Veklury is contraindicated in patients who are allergic to Veklury or any of its components. For more information, please see the U.S. full Prescribing Information available here.