Rockwell Medical Announces FDA Advisory Committee Review Of Triferic For The Treatment Of Iron Replacement And Maintenance Of Hemoglobin In Hemodialysis Patients

Rockwell Medical, Inc. RMTI, a fully integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, today announced that the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food & Drug Administration (FDA) is scheduled to review the Company's New Drug Application (NDA) for Triferic on November 6, 2014 in an afternoon session. Triferic is Rockwell's investigational drug for the treatment of iron replacement and maintenance of hemoglobin in hemodialysis patients. Triferic is under review by the Office of Hematology and Oncology Products (OHOP) Division of Hematology products. The proposed indication for Triferic is for the treatment of iron loss or iron deficiency to maintain hemoglobin in patients with hemodialysis dependent chronic kidney disease and to reduce the prescribed dose of erythropoiesis stimulating agents (ESAs) required to maintain desired hemoglobin levels. The FDA accepted the Triferic NDA for review on May 28, 2014. The PDUFA date for the FDA to complete its review of the Triferic NDA is January 24, 2015. "We are pleased to discuss the potential efficacy benefit and safety profile of Triferic with the Advisory Committee, and we will continue to work closely with the FDA during the review of the NDA," said Mr. Robert L. Chioini, Founder, Chairman and CEO of Rockwell. "Triferic has a novel mechanism of action and mode of administration which addresses the unmet need of maintenance iron therapy for the hemodialysis population."