FDA approves Triferic for iron replacement in patients with chronic kidney disease

The FDA today approved Triferic to treat iron loss in patients with chronic kidney disease who are on dialysis, according to the drug’s manufacturer.

Triferic (Rockwell Medical) is an iron compound delivered to patients via dialysate, replacing the ongoing iron losses that occur during dialysis treatment.

Triferic has demonstrated in clinical trials that it can deliver a sufficient amount of iron to the bone marrow to maintain hemoglobin and not increase ferritin, according to a press release issued by the company.

With this approval, clinicians and patients will have an alternative to IV iron, which may be less effective because it is re-routed through the liver and can be blocked by the immune system.

Anemia is a common occurrence for patients with chronic kidney disease, primarily because of their dialysis treatment but sometimes a result of an inability to produce red blood cells.

“[Triferic] is the first drug approved to replace ongoing iron losses and to maintain hemoglobin levels in hemodialysis patients,” Robert L. Chioini, CEO of Rockwell Medical, said in a press release. “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.”

More than 1,400 patients were treated with Triferic and more than 100,000 individual administrations were given, according to data released by Rockwell.

Despite some initial concerns over inefficient data for the drug, Rockwell received a boost from the FDA advisory panel that recommended approval last November by a vote of 8-3.