AstraZeneca’s investigational anaemia treatment, roxadustat, has proved successful in two Phase III trials that evaluated the efficacy and safety of the drug.
The trials, Study 806 and 808, evaluated roxadustat in Chinese patients with anaemia caused by chronic kidney disease (CKD) who are either dialysis-dependent (DD) or non-dialysis-dependent (NDD), respectively.
Data published in The New England Journal of Medicine found that the trial met its primary efficacy endpoint of a mean change in haemoglobin (Hb) from baseline averaged over weeks 23-27 for patients treated with roxadustat compared to epoetin alfa. This means that the drug was statistically non-inferior.
In a subgroup analysis of patients with inflammation marked by elevated c-reactive protein (CRP), roxadustat also achieved consistent Hb control regardless of the patients' inflammation status, compared to epoetin alfa.
The safety profile of roxadustat in both studies was consistent with previous clinical trials of roxadustat in the CKD patient population.
Mene Pangalos, executive vice president, BioPharmaceuticals R&D, mentioned that the company is “pleased that The New England Journal of Medicine has recognised the significance of the Phase III clinical trial programme in China for roxadustat. There are 120 million patients living with chronic kidney disease in China, a disease that is often associated with anaemia which can contribute to increased mortality.”
He continued, “These trials demonstrate that hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs) like roxadustat may be able to more effectively address anaemia in CKD than the current standard of care, specifically in the Chinese patient population.”
The drug is part of a new therapeutic class, acting as an inhibitor of hypoxia-inducible factor prolyl hydroxylase administered orally.