FDA approves new iron replacement drug

FDA approved ferric pyrophosphate citrate (Triferic, Rockwell Medical Inc.) for commercial sale as an iron replacement product to maintain hemoglobin in adult patients with hemodialysis dependent chronic kidney disease.

Novel new drugs approved in 2014

Triferic replaces the 5 mg to 7 mg of iron patients tend to lose during each dialysis session.

“Iron is given in free-standing dialysis clinics,” according to Rockwell Medical spokesperson Jerry Isaacson, Ph.D. “This drug is the first approved maintenance iron therapy for hemodialysis patients. It is important for chronic hemodialysis providers because it replaces the ongoing losses of iron at each treatment and will reduce the need for IV iron.”

FDA drug approvals

FDA reviewed safety and efficacy data from Rockwell’s overall clinical program. During the clinical program, 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.

“Until now, there is no drug approved to replace iron losses and maintain hemoglobin [Hgb] in hemodialysis patients,” said Isaacson. “This is the first maintenance iron therapy for hemodialysis patients. It replaces the ongoing iron losses that hemodialysis patients over the course of their dialysis treatment, due to retained blood in the dialyzer circuit, GI losses and routine blood draws for laboratory evaluations. It replaces iron losses at each treatment and maintains hemoglobin concentrations, and does not increase iron stores [ferritin] in the body. It is the only iron in the world delivered via dialysate.”

This and the drug’s method of action, where it binds immediately to transferrin and works with erythropoietin stimulating agents generating healthy red blood cells, make it unique and superior to IV iron as a maintenance therapy. IV iron is not indicated for iron replacement and maintenance of Hgb, and therefore it is not ideal for that purpose, according to Isaacson.