EU approves Fexeric (ferric citrate coordination complex) for hyperphosphatemia- Keryx Biopharmaceuticals

Keryx Biopharmaceuticals 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.

The European Commission's decision is based on evidence from approximately 1900 patients, including two key clinical trials: a Phase II, non-dialysis study and a 58-week, Phase III registration trial. In the Phase III trial, ferric citrate effectively reduced serum phosphorus levels to within the KDOQI guidelines range of 3.5 mg/dL to 5.5 mg/dL, the primary endpoint. These data were published in 2014 in the Journal of the American Society of Nephrology. The most commonly reported adverse reactions in dialysis-dependent CKD patients during treatment were discolored feces (18%) and diarrhea (13%).

Comment: The drug's market entry may well be affected by generics of Sanofi's Renvela and Shire's Fosrenol, two phosphate-lowering therapies indicated for dialysis patients. Keryx is emphasising Zerenex's secondary benefits in serum iron and ferritin, calling its drug a differentiated product in a crowded field. So far the treatment is the only phosphate binder that boosts the body's stores of iron and decreases the need for additional treatments.