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Astellas Pharma and FibroGen today 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
Roxastat is the first oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) approved by the European Union
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
Reference materials:
[1] Astellas Receives European Commission Approval for First-in-Class EVRENZO™ (roxadustat) for Adult Patients with Symptomatic Anemia of Chronic Kidney Disease.
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