Rockwell Medical announced that the Food and Drug Administration (FDA) has approved Triferic (soluble ferric pyrophosphate) as an iron replacement product to maintain hemoglobin in adults with hemodialysis dependent chronic kidney disease. Triferic is the first treatment approved to replace ongoing iron loss and to maintain hemoglobin levels in patients on hemodialysis.

Triferic is administered via dialysate directly to the bone marrow, bypassing iron storage in the liver or reticuloendothelial system. Triferic is introduced into bicarbonate concentrate at the dialysis clinic and then mixed into the dialysate. It then enters the blood where it immediately binds to transferrin and is transported to the erythroid precursor cells to be incorporated into hemoglobin. Triferic allows for improved iron delivery and prevents iron-induced liver damage.

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The safety and efficacy of Triferic was reviewed in a clinical program that evaluated over 1,400 patients treated with Triferic. Study results demonstrated Triferic to be a highly-differentiated iron delivery therapy with a safety profile similar to that of placebo.

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