Keryx Receives European Approval for Fexericx for the Treatment of Hyperphosphatemia in Adults With Chronic Kidney Disease

Keryx Biopharmaceuticals, Inc.

today announced that the European Commission has approved Fexeric® (ferric citrate coordination complex) for the control of elevated serum phosphorus levels, or hyperphosphatemia, in adults with chronic kidney disease (CKD), including both dialysis and pre-dialysis patients. The European Commission considered ferric citrate coordination complex a New Active Substance, which provides 10 years of data and marketing exclusivity in Europe. "We are pleased that this medicine was approved for broad use, in both the pre-dialysis and dialysis settings, to control hyperphosphatemia in adults with chronic kidney disease," said John Neylan, M.D., chief medical officer of Keryx. "Importantly, the EU product information contains data that is reflective of Fexeric's full clinical profile, including all of the primary and secondary endpoint data from the Phase 3 study. With Fexeric's broad label, nephrologists have a new, well tolerated and effective phosphate binder to control hyperphosphatemia as the patient progresses through the late stages of CKD and into dialysis." "The differentiated profile of ferric citrate will be a new treatment option for our patients on dialysis and pre-dialysis," said Gilbert Deray, MD, Professor of Nephrology at Université Paris 6 Pierre et Marie Curie in Paris