FDA approves ferric citrate, invented at U-M, for CKD

Drug developed by U-M professor emeritus Chen Hsu

In September, 2014, the Food and Drug Administration granted approval for the drug ferric citrate, shown to lower phosphate levels in patients with chronic kidney disease (CKD).  Licensed to Keryx Biopharmaceuticals, Inc., ferric citrate was invented by U-M emeritus professor Chen Hsu, M.D.

CKD is characterized by an ever-worsening loss of kidney function. Kidneys are unable to flush out waste, resulting in hyperphosphatemia, an abnormally high level of phosphate in the blood.  CKD can also cause severe iron deficiency. Ferric citrate binds to any phosphate ingested with food, making it impossible for the body to absorb it. 

The FDA approval is conditional on providing a safety warning label specifying that patients receiving additional iron intravenously might need to cut dosage or stop additional iron therapy as ferric citrate has been shown to increase iron levels. Although ferric citrate is currently the only drug in its class to increase iron stores in the body, the FDA-mandated label does not include the corresponding benefits the drug may have in the treatment of anemia.

Ferric citrate is also being tested in pre-dialysis patients, with late-stage tests expected soon. 

To consult with one of nephrology specialists or to refer a patient, contact M-LINE 24 hours-a-day, 7 days-a-week at 800-962-3555.