FDA approves Keryx's ferric citrate

FDA approved ferric citrate from Keryx Biopharmaceuticals Inc. (NASDAQ:KERX) to treat hyperphosphatemia in dialysis-dependent patients with chronic kidney disease (CKD). FDA contraindicated the drug in patients with iron overload syndromes such as hemochromatosis.

Keryx has not disclosed the U.S. price of the drug. It plans to launch the oral ferric iron-based phosphate binder within 12 weeks. EMA is reviewing an MAA for ferric citrate and is expected to make a decision in mid-2015. Keryx has worldwide rights to the product, including Japan but excluding the rest of the Asia Pacific region, from Panion & BF Biotech Inc. (Taipei, Taiwan). Japan approved the drug in January to treat hyperphosphatemia in CKD patients. ...