The FDA has approved ferric citrate (formerly known as Zerenex) for the control of serum phosphorus levels in patients with chronic kidney disease (CKD).

The approval was based on data from a phase 3 clinical trials showing that ferric citrate effectively reduced serum phosphorus levels to well within the range of 3.5–4.4 mg/dL recommended by KDOQI [Kidney Disease Outcomes Quality Initiative] guidelines. It also resulted in increased ferritin and transferrin saturation.

In a press release issued by the drug’s maker, Keryx Biopharmaceuticals, Inc., lead investigator Julia Lewis, MD, a nephrologist and professor of medicine at Vanderbilt University Medical Center in Nashville, said she believes the drug “offers clear benefits to patients and represents a new way for physicians to manage hyperphosphatemia.”

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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,” Dr. Lewis stated.

Keryx CEO Ron Bentsur said the company looks forward to bringing ferric citrate to the U.S. market within the next 12 weeks.