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 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.

Ferric citrate is currently marketed in the United States under the brand name Auryxia to treat hyperphosphatemia in adults with chronic kidney disease dependent on dialysis. Keryx is conducting a Phase 3 study to potentially expand the label in the U.S. to treat iron deficiency anemia in pre-dialysis patients with chronic kidney disease.

“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,” said John Neylan, MD, chief medical officer of Keryx.

The European Commission’s decision is based on evidence from approximately 1,900 patients, including two key clinical trials: a Phase 2, non-dialysis study and a 58-week, Phase 3 registration trial. In the Phase 3 trial, ferric citrate effectively reduced serum phosphorus levels to within the KDOQI guidelines range of 3.5 mg/dL to 5.5 mg/dL (p<0.0001), the primary endpoint. These data were published in 2014 in the Journal of the American Society of Nephrology.