Positive CHMP opinion to extend the use of Veklury® (remdesivir) to treat COVID-19 in people with severe renal impairment

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the use of Veklury in COVID-19 patients with severe renal impairment, including those on dialysis.

If adopted by the European Commission (EC), Veklury will become the first and only authorized antiviral treatment that can be used to treat COVID-19 across all stages of renal disease.

People with advanced chronic kidney disease (CKD) or end stage kidney disease (ESKD) represent a population that is highly vulnerable to COVID-19. They are at increased risk of morbidity and mortality from COVID-19, and have few treatment options.

This positive opinion was based on results from the Phase 3 REDPINE trial as well as a Phase 1 Pharmacokinetic study that evaluated the safety profile of Veklury in people hospitalized for COVID-19 with severe renal impairment.