AstraZeneca has announced that its partner 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.
“Roxadustat is a long-awaited, first-in-class medicine for patients with anaemia 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,” said Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer, AstraZeneca.
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 the 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 (<5%), and mostly of Grade 1-2 severity. The adverse events observed were consistent with underlying diseases in patients with CKD.
Launch during second half of 2019
AstraZeneca and FibroGen China are collaborating on the development and commercialisation of roxadustat in China. FibroGen China, based in Beijing, is a wholly-owned subsidiary of FibroGen Inc. that sponsored the development and registration of roxadustat. FibroGen China conducted the China Phase III clinical trials and submitted the New Drug Application for registration of roxadustat to the Chinese regulatory authorities.
Following this approval, AstraZeneca will manage commercialisation activities in China, and FibroGen China will manage commercial manufacturing and medical affairs as well as continued clinical development and regulatory affairs. AstraZeneca and FibroGen expect to launch roxadustat in China during the second half of 2019.
Photo of Sean Bohen: AstraZeneca