AstraZeneca’s partner FibroGen China has secured marketing approval from the China’s National Medical Products Administration (NMPA) for roxadustat to treat anemia in chronic kidney disease (CKD) patients on dialysis.
Roxadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) indicated to treat patients who use hemodialysis or peritoneal dialysis.
It will help induce coordinated erythropoiesis, increase red blood cell count and maintain plasma erythropoietin levels within or near normal physiologic range in multiple subpopulations of CKD patients.
The approval was based on an open-label and active-control 26-week phase III trial in dialysis dependent-CKD (DD CKD) patients with anemia who have been previously treated with various forms of a generic erythropoiesis-stimulating agent (ESA).
The DD-CKD patients were randomized to secure either roxadustat or epoetin alfa in the trial.
AstraZeneca has collaborated with FibroGen China to develop and commercialize roxadustat in China.
Beijing-based FibroGen China has provided funding for the development and registration of roxadustat. The firm carried out the China Phase III clinical trials and submitted the new drug application for registration of roxadustat to the Chinese regulatory authorities.
As per terms of the deal, AstraZeneca will take responsibility of roxadustat commercialization activities in China.
FibroGen China is responsible for commercial manufacturing and medical affairs, as well as continued clinical development and regulatory affairs related to of roxadustat.
AstraZeneca and FibroGen are planning to introduce the CKD treatment in the second half of 2019 in China.
AstraZeneca global medicines development executive vice president and chief medical officer Sean Bohen said: “Roxadustat is a long-awaited, first-in-class medicine for patients with anemia in chronic kidney disease that are on dialysis.
“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.”
FibroGen, a parent firm of FibroGen China, is working with AstraZeneca to develop and commercialize roxadustat to treat anemia in patients with CKD in the US, China, and other global markets.
FibroGen and Astellas Pharma are also involved in the development and commercialization of this CKD treatment in territories, including Japan, Europe, the Commonwealth of Independent States, the Middle East, and South Africa.