European Commission approves Keryx’s Fexeric for elevated serum phosphorous

Keryx carried out a phase 2, non-dialysis study and a 58-week, phase 3 registration trial on about 1900 patients.

The company said in the phase 3 trial, ferric citrate reduced serum phosphorus levels to within the KDOQI guidelines range of 3.5 mg/dL to 5.5 mg/dL.

Discolored feces and diarrhea were the most common adverse reactions in dialysis-dependent CKD patients during treatment. The company noted that all serious adverse reactions were gastrointestinal in nature.

Keryx chief medical officer John Neylan said: "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.

"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."

It is estimated that there are around 1.3 million people diagnosed and treated with stages 3-5 CKD in the five major markets in Europe. About 750,000 of those people are estimated to have hyperphosphatemia.

The product was approved in the US in September 2014 under the brand name Auryxia. It is indicated to control serum phosphorus levels in patients with CKD on dialysis.

Keryx is undertaking a phase 3 study to expand the label in the US for treating iron deficiency anemia in pre-dialysis patients with CKD.