New York-based Keryx Biopharmaceuticals Inc. said that it has submitted a Marketing Authorization Application to the European Medicines Agency (EMA), seeking the approval of Zerenex (ferric citrate coordination complex) to treat hyperphosphatemia in patients with chronic kidney disease, including dialysis- and non-dialysis dependent.
EMA approval would provide marketing authorization in all 27 member-states of the European Union, as well as in Norway, Liechtenstein, and Iceland.
The company also has a new drug application for Zerenex under review in the United States. Keryx has completed a U.S.-based Phase 3 clinical program for Zerenex in patients with chronic kidney disease on dialysis.
In January, the company's Japanese partner, Japan Tobacco, Inc. and Torii Pharmaceutical Co. Ltd. received marketing approval for the drug, branded Riona, in Japan to treat hyperphosphatemia in patients with CKD, including dialysis and non-dialysis dependent.