Recently, Astellas Pharma and FibroGen announced that the European Commission (EC) has approved the marketing of Evrenzo (roxadustat) for the treatment of adult patients with chronic kidney disease (CKD) related symptomatic anemia.

The global incidence of CKD is 1/10, and 1/5 of the patients suffer from anemia. CKD anemia is associated with reduced quality of life and progression to adverse cardiovascular disease and kidney disease outcomes.

Roxastat is the first oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) approved by the European Union. Compared with erythropoiesis stimulants (ESA), which are usually administered in combination with iron supplements, it raises hemoglobin (Hb) levels through a different mechanism of action. As a type of HIF-PHI, Roxastat can activate the body's natural response to the decrease of oxygen levels in the blood. This response involves the adjustment of multiple coordinated processes, allowing anemia to be managed by reducing the use of intravenous iron supplements. It is worth mentioning that the drug's target "oxygen sensing pathway" won the Nobel Prize in 2019.

This approval follows the positive opinions of the European Medicines Agency (EMA) Committee on Medicines for Human Use (CHMP) and is based on the results of a pivotal Phase 3 R&D project consisting of 8 multi-center and randomized studies. The project involves 9,600 patients worldwide. The results show that, regardless of the status of dialysis and previous ESA treatment, rosastat can effectively achieve and maintain the target Hb level (10-12 g/dL) in patients with CKD symptomatic anemia. The safety profile observed in the Roxastat development project is comparable to ESA and reflects the status of CKD patients in the study.