OLYMPUS compared the drug with placebo in 2,781 non-dialysis-dependent (NDD) patients, while ROCKIES enrolled 2,133 dialysis-dependent (DD) individuals and involved comparison with epoetin alfa.
Roxadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) designed to stimulate erythropoiesis. It boosts endogenous erythropoietin production and improves iron regulation.
Compared to placebo, the drug led to a statistically significant improvement in Hb levels from baseline in OLYMPUS trial. The trial met its primary endpoint by achieving a mean increase of 1.75g/dL between weeks 28 and 52 versus 0.40g/dL with placebo.
Analysis of a secondary endpoint in a subgroup of patients with increased high-sensitivity C-reactive protein (hsCRP) levels of more than 5mg/L found a statistically significant mean increase of 1.73 g/dL with roxadustat compared to 0.62g/dL in the placebo group.
The drug showed a statistically significant improvement in Hb levels in the ROCKIES trial, with a mean increase of 0.77g/dL compared to 0.68g/dL in epoetin alfa.
In a subgroup similar to the OLYMPUS trial, the mean increase was 0.80g/dL versus 0.59g/dL.
AstraZeneca BioPharmaceuticals R&D executive vice-president Mene Pangalos said: “Anaemia is a common, serious condition among patients with chronic kidney disease.
“Results from OLYMPUS and ROCKIES reinforce the potential role that roxadustat could play in increasing haemoglobin levels and managing anaemia, which is often underdiagnosed and undertreated.”
The company will announce cardiovascular (CV) safety data from the OLYMPUS and ROCKIES trials under the pooled analyses of DD-CKD and NDD-CKD participants in the global Phase III programme.
This data will be used to support regulatory filing in the US in the coming months.
The drug currently has approval in China to treat anaemia in CKD patients, irrespective of their dialysis requirements.