NEW YORK, Oct. 8, 2013 (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) today announced that its New Drug Application (NDA) for Zerenex™ (ferric citrate coordination complex) has been accepted for filing by the U.S. Food and Drug Administration (FDA). The acceptance for filing of the NDA indicates the determination by the FDA that the application is sufficiently complete to permit a substantive review.
Ron Bentsur, the Company's Chief Executive Officer, said, "We are very pleased with the FDA's acceptance for filing of our NDA for Zerenex, as this represents an important achievement in the development of Zerenex. We believe that Zerenex has the potential to make a meaningful difference in the lives of patients with chronic kidney disease on dialysis, and we look forward to continuing to work with the FDA in its review process of the Zerenex NDA."
The Company's NDA, submitted on August 7, 2013, seeks approval for the marketing and sale of Zerenex as a treatment for elevated serum phosphorus levels, or hyperphosphatemia, in patients with chronic kidney disease (CKD) on dialysis. Included in the NDA filing are safety and efficacy datasets derived from the Company's Phase 3 registration program, which was conducted pursuant to a Special Protocol Assessment (SPA) agreement with the FDA, as well as safety and efficacy data from several additional studies, including four Phase 3 studies conducted in Japan in CKD patients on dialysis.Keryx holds a worldwide license (except for certain Asian Pacific countries) to Zerenex from Panion & BF Biotech, Inc. The Japanese rights are sublicensed by Keryx to Japan Tobacco Inc. (JT) and Torii Pharmaceutical Co., Ltd. (Torii). On January 7, 2013, JT announced the filing of its NDA with the Japanese Ministry of Health, Labour and Welfare for marketing approval of ferric citrate in Japan for the treatment of hyperphosphatemia in patients with CKD.