Research & Development
CHMP recommends extending use of Veklury for COVID-19 in severe renal impairment
26 May 2023 -

Biopharmaceutical company Gilead Sciences Inc (Nasdaq:GILD) announced on Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion for the use of Veklury (remdesivir) in COVID-19 patients with severe renal impairment, including those on dialysis.

If this recommendation is adopted by the European Commission, Veklury will become the first authorised antiviral treatment for COVID-19 across all stages of renal disease.

Around 75 million people in Europe suffer from chronic kidney disease (CKD), with advanced CKD and end-stage kidney disease (ESKD) patients being highly vulnerable to COVID-19. Mortality rates in this population can reach 21-25%.

Previous restrictions on Veklury use among patients with severe renal impairment were due to insufficient data. The positive opinion is based on a Phase 1 pharmacokinetic study and the Phase 3 REDPINE trial, which demonstrated the safety of Veklury in COVID-19 patients with severe renal impairment.

Veklury is the only antiviral in the European Economic Area (EEA) indicated for both the treatment of COVID-19 in adult and adolescent patients who do not require supplemental oxygen and are at increased risk of developing severe COVID-19, as well as adults, adolescent and paediatric patients with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation).