Keryx Biopharma files for EU approval of Zerenex

10 March 2014

US drugmaker Keryx Biopharmaceuticals (Nasdaq: KERX) has submitted a Marketing Authorization Application to the European Medicines Agency seeking the approval of Zerenex (ferric citrate coordination complex) as a treatment for hyperphosphatemia in patients with chronic kidney disease, including dialysis- and non-dialysis dependent CKD.

Ron Bentsur, chief executive of Keryx, commented: "We are pleased to have submitted our MAA, seeking European approval of Zerenex for both dialysis and pre-dialysis and believe that this marks another important milestone for Keryx."

The company's US New Drug Application for Zerenex is currently under review by the Food and Drug Administration with an assigned Prescription Drug User Fee Act (PDUFA) goal date of June 7, 2014 (The Pharma Letter August 9, 2013).

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