(RTTNews) - AstraZeneca (AZN.L, AZN) said that Roxadustat significantly increased haemoglobin levels for chronic kidney disease patients with anaemia in the late-stage III OLYMPUS and ROCKIES trials.
Roxadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) that promotes erythropoiesis by increasing endogenous production of erythropoietin and improving iron regulation and overcoming the negative impact of inflammation on haemoglobin synthesis and red blood cell production by downregulating hepcidin.
In the OLYMPUS trial, roxadustat demonstrated a statistically significant improvement in Hb levels from baseline, with a mean increase of 1.75g/dL averaged over weeks 28 to 52, compared to 0.40g/dL with placebo, the primary efficacy endpoint.
In the ROCKIES trial, roxadustat demonstrated a statistically significant improvement in Hb levels from baseline with a mean increase of 0.77g/dL averaged over weeks 28 to 52, compared to 0.68g/dL with epoetin alfa, the primary efficacy endpoint.
Roxadustat is currently approved in China for the treatment of anaemia in patients with CKD, regardless of whether they require dialysis. Data from the Phase III OLYMPUS and ROCKIES trials, together with the efficacy and pooled CV safety data from the global Phase III programme, will form part of the regulatory submission in the US, anticipated in the fourth-quarter of 2019.
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