FDA approves oral iron-based treatment for dialysis patients with hyperphosphatemia

September 10, 2014

FDA has approved Ferric Citrate (Keryx), an oral, iron-based therapy for the control of serum phosphorus levels in chronic kidney disease (CKD) patients on dialysis.

Bentsur

FDA has approved Ferric Citrate (Keryx), an oral, iron-based therapy for the control of serum phosphorus levels in chronic kidney disease (CKD) patients on dialysis.

FDA drug approvals-September 2014

Phosphate control with Ferric Citrate is within the National Kidney Foundation Kidney Disease Outcomes Quality Initiative guidelines range of 3.5 mg/dL to 5.5 mg/dL.

“Ferric Citrate is a clearly differentiated product in the dialysis setting because it represents a new way for physicians to manage hyperphosphatemia,”according to Ron Bentsur, chief executive officer of Keryx. “It is the only phosphate binder that, in addition to effectively reducing phosphate, increases iron stores, as measured by TSAT and serum Ferritin.”

“Physicians should assess iron parameters for elevations in iron stores, and may need to reduce or discontinue the dose of IV iron in patients receiving Ferric Citrate,” Bentsur added.

The potential reduction in IV iron use could lead to pharmacoeconomics benefits based on data assessing the economic impact of Ferric Citrate presented at the National Kidney Foundation 2014 spring clinical meeting.

Keryx is not disclosing cost information at this time but Ferric Citrate will be priced to reflect its value in treating patients with hyperphosphatemia, according to Betsur.

In the United States there are currently approximately 400,000 early-stage renal disease (ERSD) patients who require dialysis, with that number projected to rise in the future. The majority of ESRD patients require chronic treatment with phosphate-binding agents to lower and maintain serum phosphorus at acceptable levels. Phosphate retention and the resulting hyperphosphatemia in dialysis patients are typically associated with increased risk for heart and bone disease, and death.

Ferric Citrate is also being developed in the United States as a treatment for iron deficiency anemia in patients with Stage 3 to 5 non-dialysis dependent CKD. The pivotal phase 3 study in this indication is expected to commence in the coming weeks.

Ferric Citrate is not recommended for patients with an accumulation of iron (hemochromatosis) in their body. Treatment with ferric citrate may also lead to increased iron in storage sites. Safety of using the drug is yet to be established in patients who have gastrointestinal bleeding or inflammation.

In addition, FDA has also rejected the company’s proposed brand name, Zerenex, for the drug. Keryx is now working with FDA regarding a new brand name for the drug. The company expects to have a new brand name before the launch of the drug within the next 12 weeks.