The Company's New Drug Application (NDA) for Zerenex is currently under review by the U.S. Food and Drug Administration (FDA).
Ron Bentsur, Chief Executive Officer of Keryx, commented, "We are very pleased with the publication of the Phase 3 PERFECTED study results in a premier peer-reviewed nephrology journal and are encouraged by Zerenex's potential differentiated product profile." Mr. Bentsur added, "We thank the investigators and patients who participated in this study and look forward to potentially bringing Zerenex to market in the U.S."
Phosphorus Control is Necessary for Most ESRD Patients on Dialysis
In the United States, according to data from the U.S. Renal Data System, there are currently approximately 600,000 ESRD patients, with the number of ESRD patients projected to rise in the future. The majority of ESRD patients in the United States, more than 400,000, require dialysis. Phosphate retention and the resulting hyperphosphatemia in patients with ESRD on dialysis are associated with secondary hyperparathyroidism, renal osteodystrophy, soft tissue mineralization and an increase in adverse cardiovascular events. Hyperphosphatemia is ubiquitous in ESRD, with the majority of the patients requiring chronic treatment with phosphate-binding agents to lower and maintain serum phosphorus at acceptable levels.
Zerenex Administration Over 52 Weeks Increased Iron Stores
In addition, approximately seventy percent of dialysis patients are truly or functionally iron depleted, suffer from anemia and require treatment with IV iron and/or ESA injections. The newly published clinical trial results show that, in addition to its efficacy as a phosphate binder, Zerenex also significantly raises iron stores as measured by serum
|Contact: Amy Sullivan
Keryx Biopharmaceuticals, Inc.