Approval for Hemodialysis Drug

The US Food and Drug Administration approved ferric pyrophosphate citrate (Triferic/Rockwell) for use as an iron replacement therapy in patients with end-stage renal disease, the company announced. It is also indicated for chronic kidney disease. The drug is for adults.

The drug is delivered via dialysate. According to Rockwell, the product has an advantage over competing iron-therapy products because it can “deliver iron without increasing iron stores.”

A company officer, Raymond Pratt, MD called Triferic “a paradigm shift in the treatment of anemia” in part because it eliminates the need for intravenous iron therapy.

In its trials, the drug was tested on 1,400 patients who got Triferic a total of more than 100,000 times.

According to the company, the drug is introduced in bicarbonate concentrate at the dialysis clinic and then mixed into dialysate. Triferic crosses the dialyzer membrane and enter the blood where it binds to transferring, is transported to the erythoid precursor cells and gets incorporated into the patient’s hemoglobin. The trials “demonstrated that Triferic can effectively deliver sufficient iron to the bone marrow to maintain hemoglobin and not increase iron stores.”

Rockwell was able to conduct the trials in part through a small business waiver of the Prescription Drug User Fee Act fee for its new drug application. That saved the company $2.2 million, the company said last year.