NEW YORK — Keryx Biopharmaceuticals, Inc., today announced the submission of a new drug application to the U.S. Food and Drug Administration seeking approval for the marketing and sale of Zerenex (ferric citrate coordination complex), the company's drug candidate for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with chronic kidney disease on dialysis. The company's NDA submission is based primarily on the data sets derived from its Phase 3 registration program, which was conducted pursuant to a Special Protocol Assessment agreement with the FDA, and is also supported by efficacy and safety data from several additional studies, including four Phase 3 studies conducted in Japan in CKD patients on dialysis.
"The submission of the Zerenex NDA marks a major milestone for the Company. With approximately 1,500 patients exposed to the drug in the clinical development programs conducted by us and our Japanese partner, JT/Torii, we believe that Zerenex is a safe, effective and highly-differentiated drug candidate and today's submission brings us one step closer to potentially bringing this drug to patients who can benefit from it," said Ron Bentsue the company's CEO. "We are grateful to Dr. Julia Lewis, the Study Chair for the Zerenex Phase 3 program, and to our highly skilled internal team of clinical, manufacturing and regulatory professionals, for the time and effort they have dedicated towards this tremendous achievement," continued Bentsur.
The company also plans to submit a Marketing Authorization Application to the European Medicines Agency for regulatory approval of Zerenex in the European Union.
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. and Torii Pharmaceutical Co., Ltd. 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.
Zerenex is also in Phase 2 development in the U.S. for the management of phosphorus and iron deficiency in anemic patients with Stage 3 to 5 non-dialysis dependent CKD.