FibroGen China receives marketing approval for Roxadustat
20 December 2018 -

FibroGen China, a partner of AstraZeneca, has received marketing approval from the China's National Medical Products Administration for Roxadustat intended to treat anaemia in chronic kidney disease patients on dialysis, it was reported yesterday.

The product is a hypoxia-inducible factor prolyl hydroxylase inhibitor indicated to treat patients who use haemodialysis or peritoneal dialysis. It is intended to help induce coordinated erythropoiesis, increase red blood cell count and maintain plasma erythropoietin levels within or near normal physiologic range in multiple subpopulations of chronic kidney disease patients.

The approval was based on an open-label and active-control 26-week phase III trial in dialysis dependent- chronic kidney disease patients with anaemia who have been earlier treated with various forms of a generic erythropoiesis-stimulating agent. These patients were randomised to secure either roxadustat or epoetin alfa in the trial. AstraZeneca has collaborated with FibroGen China to develop and commercialise roxadustat in China.