Posted by Michael Wonder on 19 Dec 2018
Roxadustat approved in China for the treatment of anaemia in chronic kidney disease patients on dialysis
18 December 2018 - China is the first country to approve roxadustat.
AstraZeneca today 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. The medicine can be prescribed to patients who use haemodialysis or peritoneal dialysis.
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.
