AstraZeneca announces approval for roxadustat in China for the treatment of anaemia in chronic kidney disease patients on dialysis
19 December 2018 -

AstraZeneca Plc (LON:AZN), a science-led biopharmaceutical company, announced on Tuesday that its partner FibroGen (China) Medical Technology Development Co Ltd (FibroGen China) has now received formal marketing authorisation from the National Medical Products Administration (NMPA) for roxadustat, a first-in-class hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) and new oral treatment for patients with anaemia caused by chronic kidney disease (CKD) that are on dialysis.

Reportedly, this medicine can be prescribed to patients who use haemodialysis or peritoneal dialysis.

Anaemia caused by CKD is associated with cardiovascular disease, hospitalisation, cognitive impairment and reduced quality of life, and has been shown consistently to increase the mortality risk in patients with CKD. Anaemia becomes increasingly common among individuals with CKD as their disease progresses, affecting nearly all patients at the dialysis stage.

According to the company, roxadustat is the first approved oral HIF-PHI medicine for patients with anaemia from CKD. This approval is supported by an open-label, active-control 26-week phase III trial in dialysis dependent-CKD (DD CKD) patients with anaemia who were previously treated with various forms of a generic erythropoiesis -stimulating agent (ESA).

In this trial, these DD-CKD patients were then randomised to receive either roxadustat or epoetin alfa, an ESA. Rates of adverse events related to roxadustat observed in the trial were generally low (