Positive Opinion from CHMP of Roxadustat for CKD-Associated Anemia

Astellas Pharma, Inc. and FibroGen, Inc. announce that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion regarding the use of roxadustat for the treatment of adults with symptomatic anemia associated with chronic kidney disease (CKD). Worldwide, one in ten individuals is impacted by CKD; one in five of those are affected by anemia. Anemia in CKD, which is often untreated, is associated with significant decline in quality of life and increased risk of progression to adverse cardiovascular and renal outcomes.

If the European Commission approves roxadustat, it will be first orally administered inhibitor of hypoxia-inducible factor prolyl hydroxylase available in Europe. Roxadustat activates the body’s natural response to reduced levels of oxygen in the blood, a response that involves regulation of multiple, coordinated processes that lead to the correction of anemia and a reduction in the need for intravenous iron.

Bernhardt G. Zeiher, MD, chief medical officer at Astellas Pharma, Inc., said, “Anemia of CKD remains an under-recognized and under-treated 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. We look forward to the review and assessment by the European Commission (EC), which, if positive, would make roxadustat the first HIF-PH inhibitor approved in Europe to treat symptomatic anemia in adult patients with CKD.”

Mark Eisner, MD, MPH, chief medical officer at FibroGen, said, “Anemia of CKD significantly affects the daily lives of those living with the condition. Roxadustat’s novel mechanism of action and oral administration provide physicians with the opportunity to help redefine the management of symptomatic anemia of CKD.”

The positive position from the CHMP will be reviewed by the EC, which has the authority to approve medicines for the European Union member states, as well as Iceland, Norway, Liechtenstein, and Northern Ireland. The EC has 67 days from the CHMP opinion to issue a final decision.