FDA accepts Keryx's Zerenex NDA

Keryx Biopharmaceuticals Inc. (NASDAQ:KERX) said FDA accepted for review an NDA for Zerenex ferric citrate to treat hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis. The oral ferric iron-based phosphate binder is under review in Japan to treat hyperphosphatemia in CKD patients, with a decision expected in 1Q14. Keryx also plans to submit an MAA to EMA for Zerenex by year end. 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). ...