WIXOM, Mich., June 30, 2014 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (Nasdaq: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 U.S. Food & Drug Administration (FDA) granted its request for a small business waiver of the Prescription Drug User Fee Act (PDUFA) fee for its New Drug Application (NDA) for Triferic. Rockwell's previous small business waiver request was denied by the Small Business Office of Government Contracting based upon the ruling that the Company did not meet the proper size determination criteria, but Rockwell appealed the decision and won. Rockwell will receive a check for $2.2 million from the Department of Treasury within a few weeks. Triferic is the Company's iron-replacement drug for treating iron loss in chronic kidney disease patients receiving hemodialysis.
Rockwell's NDA for Triferic was accepted for filing by the FDA on May 28, 2014. The acceptance of the NDA indicates the determination by the FDA that the application is sufficiently complete to permit a substantive review. The NDA will be subject to a standard review and will have a PDUFA action date of January 24, 2015. The PDUFA action date is the goal date for the FDA to complete its review of the NDA.
The Company's NDA seeks approval for the marketing and sale of Triferic as an iron replacement/maintenance therapy for the treatment of iron loss or iron deficiency in adult patients with hemodialysis-dependent stage 5 chronic kidney disease (CKD 5HD). Included in the NDA filing are safety and efficacy data sets derived from the Company's Phase 3 registration program, as well as safety and efficacy data from several additional studies comprising the entire clinical program. During the clinical program more than 1,400 patients were treated with Triferic and more than 100,000 individual administrations were given. The results from the clinical trials have shown the potential for Triferic to be an effective and highly-differentiated iron delivery therapy with a safety profile similar to placebo.