EU CHMP recommends approval of Fexeric (ferric citrate coordination complex) in hyperphosphatemia- Keryx

The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for the marketing authorization of Fexeric (ferric citrate coordination complex), from Keryx, recommending approval for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in adults with chronic kidney disease. Fexeric was approved under the brand name Auryxia by the FDA in September 2014, and is indicated in the U.S. for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis.

The CHMP opinion 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 well within the KDOQI guidelines range of 3.5 mg/dL to 5.5 mg/dL. These data were published in 2014 in the Journal of the American Society of Nephrology.

The most commonly reported adverse events during treatment were discolored feces (18%) and diarrhea (13%). All serious adverse reactions were gastrointestinal in nature (abdominal pain, constipation, diarrhea, gastritis, gastritis erosive, and hematemesis). The most commonly reported adverse reactions in CKD non-dialysis patients during treatment were discolored feces (27%) constipation (13%) and diarrhea (11%).