BioCentury
ARTICLE | Company News

EMA accepts Zerenex MAA for review

April 3, 2014 12:46 AM UTC

Keryx Biopharmaceuticals Inc. (NASDAQ:KERX) said EMA accepted for review an MAA for Zerenex ferric citrate to treat hyperphosphatemia in dialysis dependent and non-dialysis dependent patients with chronic kidney disease (CKD). The product is under FDA review for CKD in dialysis patients, with a June 7 PDUFA date. In January, Japan approved the oral ferric iron-based phosphate binder as Riona. 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). ...