Keryx Biopharma files for US approval of Zerenex

Keryx Biopharmaceuticals (Nasdaq: KERX) says it has submitted a New Drug Application to the US 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 (CKD) on dialysis.

The company's NDA submission is based primarily on the datasets derived from its Phase III registration program, which was conducted under 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.

Ron Bentsur, the company's chief executive, said: "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.”