Zerenex filed at FDA for Hyperphosphataemia
Keryx Biopharmaceuticals, Inc. has announced the submission of a New Drug Application (NDA) to the FDA 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 Hyperphosphataemia, in patients with Chronic Kidney Disease (CKD) on dialysis.
The Company's NDA submission is based primarily on the datasets derived from its Phase III registration program, which was conducted pursuant to a Special Protocol Assessment (SPA) agreement with the FDA, and is also supported by efficacy and safety data from several additional studies, including four Phase III studies conducted in Japan in CKD patients on dialysis.
The Company also plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for regulatory approval of Zerenex in the European Union.
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