The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of ferric citrate coordination complex (Fexeric, Keryx Biopharmaceuticals) for hyperphosphatemia in adults with chronic kidney disease (CKD) receiving or not receiving dialysis.
"Fexeric, if approved, will be the only absorbable, iron-based phosphate binder to treat elevated serum phosphorus levels in both non-dialysis and dialysis CKD patients in Europe," the company said in a news release.
The US Food and Drug Administration approved ferric citrate under the brand name Auryxia in September 2014 for the control of serum phosphorus levels in patients with CKD on dialysis.
"The benefits with Fexeric are its ability to reduce serum phosphorus in patients with chronic kidney disease, as shown in the pivotal study where patients treated with Fexeric had a significant decrease in serum phosphorus compared with patients treated with placebo," the EMA notes in a statement announcing the positive opinion.
In the phase 3 trial, ferric citrate reduced serum phosphorus levels to "well within" the Kidney Disease Outcomes Quality Initiative guidelines range of 3.5 to 5.5 mg/dL, according to a news release from the manufacturer.
Discolored feces (18%) and diarrhea (13%) were the most common adverse events. All serious adverse reactions were gastrointestinal in nature (abdominal pain, constipation, diarrhea, gastritis, gastritis erosive, and hematemesis).
Once approved in Europe, Fexeric will be available as film-coated tablets containing 210 mg ferric iron in 1 g ferric citrate coordination complex.
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Cite this: CHMP Says Yes to Ferric Citrate for CKD - Medscape - Jul 29, 2015.