AstraZeneca and its partner FibroGen Medical Technology Development have obtained approval from China’s National Medical Products Administration (NMPA) to market roxadustat for the treatment of anaemia caused due to chronic kidney disease (CKD).
Roxadustat is an oral, small molecule, hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). It is indicated for patients who are on haemodialysis or peritoneal dialysis.
Anaemia caused by CKD is linked to cardiovascular disease, hospitalisation, cognitive impairment, reduced quality of life and enhanced mortality risk.
Roxadustat is designed to boost erythropoiesis via increased erythropoietin production and improved iron regulation. It also down regulates hepcidin to address the impact of inflammation on haemoglobin synthesis and red blood cell production.
The drug is said to be the first oral HIF-PHI approved for patients suffering with anaemia from CKD.
NMPA approval is based on data from an open-label, active-control 26-week Phase III clinical trial conducted in dialysis dependent-CKD patients with anaemia.
The trial enrolled subjects who were previously treated with different forms of a generic erythropoiesis-stimulating agent (ESA).
Adverse events associated with the drug were found to be generally low (<5%), and mostly of Grade 1-2 severity. The events were observed to be consistent with underlying diseases in patients with CKD.
AstraZeneca Global Medicines Development executive vice-president Sean Bohen said: “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.”
AstraZeneca and FibroGen China have partnered for the development and commercialisation of roxadustat in China.FibroGen China sponsored the development and registration of roxadustat, as well as performed the Phase III trials and submitted the NEW DRUG APPLICATION in the country.
Following the NMPA approval, AstraZeneca will be responsible for commercialisation activities, while FibroGen China will carry out commercial manufacturing and medical affairs along with further clinical development and regulatory affairs.
The drug is expected to launch in China in the second half of next year.