Fibrogen and AstraZeneca win Chinese approval for roxadustat

18 December 2018

London-listed AstraZeneca (LSE: AZN) has announced that its development partner FibroGen China has won approval from the Chinese regulator for roxadustat, a new first-in-class treatment for anemia caused by chronic kidney disease (CKD).

Fibrogen’s (Nasdaq: FGEN) Chinese business applied for approval for the therapy based on data from a Phase III trial in dialysis dependent-CKD (DD CKD) patients with anemia who were previously treated with various forms of a generic erythropoiesis-stimulating agent (ESA).

Roxadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) which can be prescribed to patients who use hemodialysis or peritoneal dialysis.

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