September 8, 2014
By Krystle Vermes, BioSpace.com Breaking News Staff
Keryx Biopharmaceuticals , a New York headquartered biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has approved of its drug for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis.
The company announced the news about its drug, Ferric Citrate, on Sept. 5. Ferric Citrate is formerly known as Zerenex. It has been approved for the treatment of all stages of CKD in patients in Japan since January 2014.
“We are thrilled with the FDA’s decision to approve Ferric Citrate, and look forward to bringing it to market in the U.S. within the next 12 weeks,” said Ron Bentsur, Chief Executive Officer of Keryx. “We are committed to bringing innovative therapies to the market for patients with kidney disease and are excited to be offering this important treatment option to dialysis patients.”
The FDA approval comes after the review of data from a Phase 3 registration program. In Phase 3 clinical trials, Ferric Citrate was able to reduce serum phosphorus levels to push them within the KDOQI guidelines range of 3.5mg to 5.5mg. Additionally, Ferric Citrate’s pharmacodynamic properties resulted in an increase in ferritin and transferring saturation.
“I believe that Ferric Citrate offers clear benefits to patients and represents a new way for physicians to manage hyperphosphatemia,” said Julia Lewis, M.D., lead investigator, nephrologist and Professor of Medicine at Vanderbilt University Medical Center. “Given Ferric Citrate’s pharmacodynamic properties that lead to increases in iron stores, physicians should assess and monitor iron parameters and may need to reduce the dose of or discontinue IV iron therapy.”
Patients who received Ferric Citrate experienced some adverse effects such as diarrhea, nausea, vomiting and constipation.
Ferric Citrate is Keryx Biopharmaceuticals’ primary product. The company plans to commercial launch the drug in the fourth quarter of 2014 in the U.S.
Ferric Citrate is also being developed in the U.S. as a form of treatment for iron deficiency anemia, specifically in patients who have Stage 3 to 5 non-dialysis dependent chronic kidney disease. A Phase 3 study looking at this possibility is expected to commence in the coming weeks.
More than 20 million people in the U.S. are thought to have chronic kidney disease, according to the Centers for Disease Control and Prevention.
