FDA Approves Iron Replacement Product for Dialysis Patients

The FDA has approved Rockwell Medical’s Triferic, an iron compound delivered during dialysis, as an iron replacement product to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease.

This latest FDA nod was based on the results of Rockwell's clinical program for Triferic, which enrolled more than 1400 patients. The research team found that Triferic could effectively deliver sufficient iron to the bone marrow to maintain hemoglobin without increasing iron stores. In addition, the safety profile of Triferic was found to be similar to that of placebo.

“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,” said Robert L. Chioini, Founder, Chairman and CEO of Rockwell, in a press release. “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 see Triferic as a paradigm shift in the treatment of anemia,” added Raymond Pratt, MD, Chief Medical Officer of Rockwell. “Importantly, Triferic is the first product that can safely allow dialysis patients to maintain target hemoglobin without the need for IV iron. Data suggests that we have been overloading our dialysis patients with IV iron, and this is an increasing concern to the hemodialysis community. Triferic offers a more physiologic way to deliver and maintain iron balance in hemodialysis patients.”