The U.S. Food and Drug Administration (FDA) has approved Rockwell Medical's drug for iron replacement in chronic kidney disease patients who are undergoing dialysis.
The drug, dubbed Triferic, replaces between five and seven milligrams of iron in a patient who is receiving dialysis, Reuters reported.
"We are extremely pleased with the FDA approval of Triferic. It is the first drug approved to replace ongoing iron losses and to maintain hemoglobin levels in hemodialysis patients," Robert L. Chioini, Rockwell's founder, chairman and CEO, said in a news release reported by CNN Money. "Triferic's unique ability to be delivered via dialysate and to deliver iron without increasing iron stores strengthens its potential to become the market-leading iron therapy treatment for hemodialysis patients. We view today's FDA decision as a major development both for Rockwell and for the entire hemodialysis patient population who now have a significantly better treatment option for addressing their iron losses."
The drug can be added directly to the dialysis solution and is the first approved drug to maintain target hemoglobin without the need for intravenous iron. With Triferic, iron is delivered directly to the bone marrow, which is more efficient than iron that is administered intravenously, Reuters reported.
"Triferic is introduced into bicarbonate concentrate, on-site at the dialysis clinic, and subsequently mixed into dialysate. Once in dialysate, Triferic crosses the dialyzer membrane and enters the blood where it immediately binds to transferrin and is transported to the erythroid precursor cells to be incorporated into hemoglobin," according to the release.
Keryx Biopharmaceuticals is also in late-trial stages for the drug Auryxia, which is designed to treat iron deficiency in non-dialysis chronic kidney disease patients.
