Keryx Biopharmaceuticals Inc. said today that it received U.S. Food and Drug Administration approval for ferric citrate (formerly known as Zerenex) for the control of serum phosphorus levels in patients with end-stage renal disease.
“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, CEO of Keryx.
The U.S. approval of ferric citrate was based on data from its Phase 3 registration program. In the Phase 3 clinical trials, the drug effectively reduced serum phosphorus levels to well within the range of 3.5 mg/dL to 5.5 mg/dL. In addition to the effects on serum phosphorus levels, use of ferric citrate also resulted in increased ferritin and transferrin saturation (TSAT). The most common adverse events for ferric citrate treated patients were gastrointestinal-related, including diarrhea, nausea, vomiting and constipation.
“I believe that ferric citrate offers clear benefits to patients and represents a new way for physicians to manage hyperphosphatemia,” said Julia Lewis, MD, 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.”