First-in-class treatment for anemia of CKD gains approval in Great Britain

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has licensed Evrenzo (roxadustat) for the treatment of adult patients with symptomatic anemia associated with chronic kidney disease (CKD). The approval was granted to Japanese drugmaker Astellas Pharma (TYO: 4503).

Roxadustat is the first and only hypoxia-inducible factor, prolyl hydroxylase inhibitor (HIF-PHI) licensed for use in Great Britain. The licence was based on results from a comprehensive pivotal Phase III program comprising of eight multicenter and randomized studies, which involved 9,600 patients worldwide.

The results of this program support roxadustat as efficacious in achieving and maintaining target hemoglobin (Hb) levels (10–12 g/dL) in patients with symptomatic anemia of CKD regardless of dialysis status and irrespective of prior erythropoiesis-stimulating agent (ESA) treatment, commented Astellas. The safety profile observed in the roxadustat development program is reflective of the CKD populations studied and comparable to ESAs.