Rockwell Medical renames iron drug for dialysis patients Triferic
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The U.S. Food & Drug Administration has accepted the proposed trade name Triferic for Rockwell Medical's investigational iron-delivery drug, previously known as Soluble Ferric Pyrophosphate (SFP), which is intended for treating iron deficiency in chronic kidney disease patients receiving hemodialysis, Rockwell announced.
"We believe that upon FDA approval, Triferic will become the new standard of care in iron therapy," said Rob Chioini, chairman and CEO of Rockwell Medical.
Rockwell recently announced successful top-line results from its long-term Phase 3 CRUISE-1 and CRUISE-2 efficacy studies of Triferic. In both studies, Triferic met the primary endpoint, demonstrating a statistically significant mean change in hemoglobin from baseline to end-of-treatment.