AstraZeneca announced that the primary efficacy endpoints were met in the Phase 3 OLYMPUS and ROCKIES trials evaluating roxadustat for the treatment of patients with anemia in chronic kidney disease (CKD) that are either non-dialysis-dependent (NDD) or dialysis-dependent (DD), respectively.
Roxadustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), is a potential first-in-class agent to treat anemia in CKD. Roxadustat is expected to promote erythropoiesis by increasing endogenous production of erythropoietin and downregulating hepcidin.
The double-blind, placebo-controlled OLYMPUS trial (N=2781) compared the safety and efficacy of roxadustat vs placebo for the treatment of patients with anemia in CKD stages 3,4, and 5 whose disease progression was moderate to severe and who are NDD. Roxadustat was associated with a statistically significant and clinically meaningful improvement in mean change from baseline in hemoglobin levels over weeks 28-52 vs placebo, meeting the primary endpoint.
The open-label, active-controlled ROCKIES trial (N=2133) compared the safety and efficacy of roxadustat vs an erythropoietin-stimulating agent (ESA), epoietin alfa, for the treatment of patients with anemia in CKD who are DD. A statistically significant improvement in mean change from baseline in hemoglobin levels averaged over weeks 28-52 was observed with roxadustat vs epoetin alfa.
“These results add to the growing body of evidence for roxadustat, which is part of the largest clinical program worldwide in evaluating the novel class of HIF-PHI,” said Sean Bohen, Executive Vice-President, Global Medicines Development and Chief Medical Officer. “This is a significant milestone in the role roxadustat can play to help address a high unmet need in anemia associated with chronic kidney disease, which today is underdiagnosed and in many cases undertreated.”
For more information visit Astrazeneca-US.com.