TOKYO, June 25, 2021 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and FibroGen, Inc. (Nasdaq: FGEN, CEO: Enrique Conterno, "FibroGen") today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion relating to the use of roxadustat for the treatment of adult patients with symptomatic anemia associated with chronic kidney disease (CKD).1 CKD impacts one in 10 people globally, of whom one in five are affected by anemia.2, 3 Anemia of CKD is associated with significant impairment in quality of life and progression to adverse cardiovascular (CV) and renal outcomes.4-6 Anemia of CKD is often untreated or not treated to target.4-6
If approved by the European Commission (EC), roxadustat will be the first orally administered inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase (PH) available in Europe. Roxadustat increases hemoglobin (Hb) levels through a different mechanism of action compared to erythropoiesis-stimulating agents (ESAs). 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 lead to the correction of anemia with a reduced need for intravenous iron.
“Anemia of CKD remains an under recognized and undertreated condition. Today’s 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,” said Bernhardt 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.”
The positive CHMP opinion is based on the results from a comprehensive pivotal Phase 3 program comprising of eight multicenter and randomized studies, which involved 9,600 patients worldwide.7-12 The results of this program support roxadustat as efficacious in achieving and maintaining target Hb levels (10-12g/dL) in patients with symptomatic anemia of CKD regardless of dialysis status and irrespective of prior ESA treatment.7-11 The safety profile observed in the roxadustat development program is reflective of the CKD populations studied and comparable to ESAs.7-12
“Anemia of CKD significantly affects the daily lives of those living with the condition,” said Mark Eisner, M.D., M.P.H, Chief Medical Officer, FibroGen. “Roxadustat’s novel mechanism of action and oral administration provide physicians with the opportunity to help re-define the management of symptomatic anemia of CKD.”
The positive opinion from the CHMP will now be reviewed by the EC, which has the authority to approve medicines for European Union member states, as well as Iceland, Norway, Liechtenstein and Northern Ireland.13 The EC has 67 days from the CHMP opinion to issue a final decision.
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