Keryx Submits NDA for Hyperphosphatemia Drug, Zerenex
Keryx Biopharmaceuticals announced that it has submitted a New Drug Application (NDA) to the FDA for approval of Zerenex (ferric citrate coordination complex) for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.
The NDA submission is based on data from its Phase 3 registration program as well as efficacy and safety data from several additional studies, including four Phase 3 studies conducted in CKD patients on dialysis.
Zerenex is also in Phase 2 development in the U.S. for the management of phosphorus and iron deficiency in anemic patients with Stage 3–5 non-dialysis dependent CKD.
For more information call (212) 531-5965 or visit Keryx.com.