The U.S. Food and Drug Administration approved Rockwell Medical Inc.'s Triferic as an iron replacement product to maintain hemoglobin in adult patients on hemodialysis.

Triferic is delivered to hemodialysis patients via dialysate, replacing the ongoing iron losses that occur during their dialysis treatment, according to Rockwell. The drug is introduced into bicarbonate concentrate, on-site at the dialysis clinic, and subsequently mixed into dialysate. Once in dialysate, Triferic crosses the dialyzer membrane and enters the blood where it immediately binds to transferrin and is transported to the erythroid precursor cells to be incorporated into hemoglobin. In completed clinical trials to date, Triferic has demonstrated that it can effectively deliver sufficient iron to the bone marrow to maintain hemoglobin and not increase iron stores.

"We see Triferic as a paradigm shift in the treatment of anemia. Importantly, Triferic is the first product that can safely allow dialysis patients to maintain target hemoglobin without the need for IV iron," said Dr. Raymond Pratt, chief medical officer of Rockwell. "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."

The approval sent Rockwell's shares up about 15% in premarket trading, Reuters reported.  Stifel Nicolaus analyst Annabel Samimy told Reuters that said she expected Triferic to hit peak sales of $200 million-$250 million in the United States.