Keryx Biopharmaceuticals’ Fexeric has been approved in Europe as a treatment for controlling phosphorus levels in adults with chronic kidney disease.
The approval means that Fexeric (ferric citrate) is the first and only absorbable, iron-based phosphate binder to treat hyperphosphataemia in both non-dialysis and dialysis patients with CKD.
The decision for approval comes on the back of data from two studies involving approximately 1900 patients. In a phase III trial, ferric citrate was able to effectively reduce serum phosphorus levels to within normal ranges.
John Neylan, CMO at Keryx, said: “We are pleased that this medicine was approved for broad use, in both 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 III 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.”
Managing patients on dialysis is complex as many chemicals such as iron and phosphorous are out of balance. It is estimated that there are around 1.3 million people diagnosed and treated with stages 3-5 CKD, with approximately 750,000 of these people having hyperphosphatemia.
Greg Madison, CEO at Keryx Biopharmaceuticals, said: “EC approval is another validation by a global regulatory agency of the medicine’s profile, and is another milestone in our efforts to expand the reach of ferric citrate to treat patients with renal disease.”
“We expect to finalise our commercial strategy by the end of 2015.”