FDA Approves Ferric Citrate for CKD Dialysis Patients

Larry Hand

September 05, 2014

The US Food and Drug Administration (FDA) has approved ferric citrate (formerly Zerenex, Keryx Biopharmaceuticals) for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) who are receiving dialysis, according to a company announcement today.

Keryx Biopharmaceuticals, of New York City, plans to make ferric citrate available to US patients receiving dialysis within about 12 weeks, according to the statement.

The FDA approval came after phase 3 trial data showed that ferric citrate is effective at reducing hyperphosphatemia and improving iron levels in patients receiving dialysis, as previously reported by Medscape Medical News.

The most common adverse events for ferric citrate–treated patients were gastrointestinal-related, including diarrhea, nausea, vomiting, and constipation, according to the company.

"I believe that ferric citrate offers clear benefits to patients and represents a new way for physicians to manage hyperphosphatemia," Julia Lewis, MD, lead investigator, nephrologist, and professor of medicine at Vanderbilt University Medical Center in Nashville, Tennessee, said in the company announcement. "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 [intravenous] iron therapy."

Keryx is in the process of determining a new brand name for ferric citrate after the FDA recently informed the company that Zerenex had to be rescinded. Although a brand name is not a prerequisite for launching a product, Keryx is trying to have a new brand name by the US launch.

Keryx is also developing ferric citrate as a US treatment for iron deficiency anemia in patients with stage 3 and 5 CKD who are not dependent on dialysis. The phase 3 study on that use may begin within weeks.

Keryx has filed an application with the European Medicines Agency for marketing ferric citrate as a treatment for CKD in patients receiving or not receiving dialysis.

The treatment won approval for marketing in Japan in January 2014 for patients with all stages of CKD.


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