Keryx Biopharmaceuticals Receives Positive Scientific Advice from the European Medicines Agency for Zerenex in Hyperphosphatemia

Keryx Biopharmaceuticals, Inc. KERX, announced today that it has received positive Scientific Advice from the European Medicines Agency for the development of Zerenex for the management and control of serum phosphorus in end-stage renal disease patients undergoing dialysis, and in pre-dialysis chronic kidney disease patients. The Scientific Advice from the EMA indicates that the Company's current Phase 3 program in the United States, if successful, in conjunction with safety data generated from other clinical studies with Zerenex, is considered sufficient to support a European marketing authorization application to the EMA for the indication in ESRD patients on dialysis. Therefore, the Company believes that it will not need to conduct any additional clinical trials with Zerenex in order to obtain European approval in the dialysis setting.
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