China becomes first country to approve roxadustat in chronic kidney disease

pharmafile | December 19, 2018 | News story | Research and Development, Sales and Marketing AstraZeneca, China, chronic kidney disease, pharma 

AstraZeneca has announced that its partner Fibrogen has secured the first national approval for its hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) roxadustat, with China becoming the first country to authorise the drug.

The approval is in the treatment of anaemia as a result of chronic kidney disease (CKD) in patients that are on dialysis; it is the first oral HIF-PHI approved in that condition, and can be used in those who use haemodialysis or peritoneal dialysis. Anaemia caused by CKD has been linked to cardiovascular disease and has been shown to increase mortality risk in those with CKD.

The decision was backed up by data derived from a 26-week Phase 3 trial, examining dialysis dependent-CKD (DD CKD) patients with anaemia who were previously treated with various forms of a generic erythropoiesis-stimulating agent (ESA).

“Roxadustat is a long-awaited, first-in-class medicine for patients with anaemia in chronic kidney disease that are on dialysis,” commented Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca. “This first approval of roxadustat in China is a significant step towards achieving our ambition to transform care in a condition where prevalence in China is increasing.”

It is estimated that around 120 million Chinese patients could benefit from the approval, with that number expected to rise.

Matt Fellows

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