Keryx Biopharmaceuticals, a biopharmaceutical company focused on products geared towards patients with renal disease and their healthcare providers, is pleased to announce the European Commission has granted Fexeric (ferric citrate coordination complex) approval as a treatment for hyperphosphatemia in adult CKD patients, regardless of dialysis. Fexeric has been given a New Active Substance designation as well, which guarantees it 10 years of marketing and data exclusivity in the EU.
“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,” said John Neylan, M.D., chief medical officer of Keryx. “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.”
“The differentiated profile of ferric citrate will be a new treatment option for our patients on dialysis and pre-dialysis,” said Gilbert Deray, MD, professor of nephrology at Université Paris 6 Pierre et Marie Curie in Paris and Nephrologist and head of the department of nephrology at Pitié-Salpêtrière University Hospital. “I look forward to using this medicine to control phosphorus levels when it becomes available in the EU.”
The EC’s approval is backed by Keryx Biopharma’s findings from studies on 1900 CKD patients, including a pair of pivotal clinical studies: a Phase II non-dialysis study and a Phase III registration study that spanned 58 weeks. During the latter study, researchers reported that ferric citrate was able to significantly reduce serum phosphorus levels to fall inside KDOQI guidelines range of 3.5 mg/dl to 5.5 mg/dl, meaning the drug was able to meet the set primary endpoint. These findings were published in 2014 in the Journal of the American Society of Nephrology.
“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,” said Greg Madison, chief executive officer. “We continue to work with potential partners regarding commercialisation in the EU, and expect to finalise our commercial strategy by the end of 2015.”
Ferric citrate coordination complex for hyperphosphatemia is nothing new to the CKD treatment market in the US, with a product under brand name Auryxia given FDA approval last September 2014. Keryx Biopharma is currently working on completing a Phase III study that can potentially bring Fexeric to the country as a method to treat iron deficiency anemia in pre-dialysis CKD patients.