European Commission approves Evrenzoto treat adult patients with symptomatic anemia associated with chronic kidney disease – Astellas + FibroGen Inc.

Astellas Pharma Inc.and FibroGen, Inc. announced that the European Commission (EC) has approved Evrenzo (roxadustat) for the treatment of adult patients with symptomatic anemia associated with chronic kidney diseases (CKD). CKD impacts one in 10 people globally, of whom one in five are affected by anemia. Anemia of CKD is often untreated or not treated to target, and is associated with reduced quality of life and progression to adverse cardiovascular (CV) and renal outcomes.

Roxadustat is the first orally administered HIF-PH inhibitor available in the European Union. Roxadustat increases hemoglobin (Hb) levels through a different mechanism of action compared to injectable erythropoiesis-stimulating agents (ESAs) which are typically co-administered with intravenous iron. As a HIF-PH inhibitor, roxadustat activates the body’s natural response to reduced oxygen levels in the blood. This response involves the regulation of multiple, coordinated processes that allow management of anemia with a reduced use of intravenous iron..