Astellas’ EVRENZO▼™ (roxadustat) to be reimbursed under the High Tech Drugs Scheme in Ireland For Adults With Symptomatic Anaemia Associated With Chronic Kidney Disease (CKD)

Astellas Pharma Company Ltd. (part of the Astellas Pharma Inc group TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) is pleased to announce that EVRENZO™ (roxadustat) has been granted reimbursement, in line with its marketing authorisation under the High Tech Drugs Scheme in Ireland from 1^st September, 2022, as an option for treating adult patients with symptomatic anaemia associated with CKD.

Roxadustat is the first and only HIF-PH inhibitor licensed and reimbursed for use in Ireland. The licence was based on results from a comprehensive pivotal Phase 3 programme comprising of eight multicentre and randomised studies, which involved 9,600 patients worldwide.^6-11 The results of this programme support roxadustat as efficacious in achieving and maintaining target haemoglobin (Hb) levels (10–12 g/dL) in patients with symptomatic anaemia of CKD regardless of dialysis status and irrespective of prior erythropoiesis-stimulating agent (ESA) treatment.^6-10 The safety profile observed in the roxadustat development programme is reflective of the CKD populations studied and comparable to ESAs.^6-11