FDA approves Triferic for CKD-Rockwell Medical

The FDA has approved Triferic (soluble ferric pyrophosphate citrate), from Rockwell Medical, for commercial sale as an iron replacement product to maintain haemoglobin in adult patients with haemodialysis-dependent chronic kidney disease. The FDA reviewed safety and efficacy data from Rockwell's overall clinical programme, in which more than 1,400 patients were treated with Triferic and more than 100,000 individual administrations were given. The results from the clinical trials have shown Triferic to be an effective and highly-differentiated iron delivery therapy with a safety profile similar to placebo.

Triferic is introduced into bicarbonate concentrate, on-site at the dialysis clinic, and subsequently mixed into dialysate. Once in dialysate, Triferic crosses the dialyser membrane and enters the blood where it immediately binds to transferrin and is transported to the erythroid precursor cells to be incorporated into haemoglobin. In completed clinical trials to date, Triferic has demonstrated that it can effectively deliver sufficient iron to the bone marrow to maintain haemoglobin and not increase iron stores (ferritin).