FDA Approves Triferic for Iron Replacement in Dialysis

Disclosures

January 26, 2015

The US Food and Drug Administration (FDA) has approved soluble ferric pyrophosphate (Triferic, Rockwell Medical) to replace iron and maintain hemoglobin in adults with chronic kidney disease who are undergoing dialysis.

Delivered during hemodialysis via dialysate, soluble ferric pyrophosphate dispenses with the need for intravenous iron. Administering the agent three to four times a week can compensate for an estimated 5 mg of iron loss from dialysis-related blood losses, according to the manufacturer.

"Data suggests that we have been overloading our dialysis patients with [intravenous] iron, and this is an increasing concern to the hemodialysis community," said Raymond Pratt, MD, chief medical officer of Rockwell Medical, in a news release. "Triferic offers a more physiologic way to deliver and maintain iron balance in hemodialysis patients."

When the FDA's Oncologic Drugs Advisory Committee recommended approval of soluble ferric pyrophosphate in November 2014, it said the manufacturer should conduct postapproval studies into the safety and efficacy of the agent during prolonged use. At that time, FDA staff members told the committee that the clinical trials in support of soluble ferric pyrophosphate were fuzzy on that subject. They said that although treatment duration in the clinical trials was planned for up to 48 weeks, only 18% of patients went that long in the trial, and 44% completed only 24 weeks.

In the approval letter it issued on January 23, however, the FDA did not require Rockwell Medical to perform the recommended postapproval studies.

More information about today's announcement is available on the FDA website.

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