Astellas Receives Positive CHMP Opinion for EVRENZO™ (roxadustat) for Adult Patients with Symptomatic Anemia of Chronic Kidney Disease
Todays positive CHMP opinion marks a significant step in providing patients with a new and important treatment option for anemia associated with CKD, regardless of dialysis status, saidBernhardt G. Zeiher, M.D., Chief Medical Officer, Astellas.
- Todays positive CHMP opinion marks a significant step in providing patients with a new and important treatment option for anemia associated with CKD, regardless of dialysis status, saidBernhardt G. Zeiher, M.D., Chief Medical Officer, Astellas.
- We look forward to the review and assessment by the European Commission which, if positive, would make roxadustat the first HIF-PH inhibitor approved in Europe to treat symptomatic anemia in adult patients with CKD.
- Roxadustat is also in Phase 3 clinical development for anemia associated with myelodysplastic syndromes (MDS) and Phase 2 for chemotherapy-induced anemia (CIA).
- The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD).