Rockwell Medical, Inc. Receives FDA Approval for Triferic AVNU (Ferric Pyrophosphate Citrate), Intravenous Formulation of Triferic for Replacement of Iron and Maintenance of Hemoglobin in Hemodialysis Patients

– Enhances Triferic platform by providing patients with greater access to Rockwell Medical’s innovative therapeutic by expanding administration options for clinicians –

– Major milestone supports the potential for expanding global adoption of Triferic and transforming the standard of care for anemia management in hemodialysis patients –

WIXOM, Mich., March 27, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) (“Rockwell Medical” or the “Company”), a biopharmaceutical company dedicated to transforming anemia management and improving outcomes for patients around the world, today announced that the U.S. Food and Drug Administration (“FDA”) has approved its New Drug Application (“NDA”) for its intravenous formulation of Triferic, Triferic AVNU. With this approval, Triferic AVNU joins Triferic Dialysate as the only FDA-approved products indicated to replace iron and maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease.

Triferic is a novel, physiologic iron maintenance therapy that provides bioavailable iron to replace iron lost during every dialysis treatment and maintain hemoglobin. While Triferic Dialysate is designed to be administered via liquid bicarbonate, Triferic AVNU is designed for direct intravenous infusion, which provides hemodialysis patients with greater access to the Triferic platform and expands administration options for clinicians. Triferic AVNU can be administered regardless of a dialysis center’s mode of bicarbonate delivery. Many dialysis centers in international markets and an increasing number of dialysis centers in the U.S. have converted to the use of dry bicarbonate cartridges or bags and on-line dialysate generation, which is not compatible with Triferic Dialysate.

“The approval of Triferic AVNU is a major milestone as we further progress toward our goal of transforming anemia management across the globe. With Triferic AVNU, more adult hemodialysis patients in the U.S will have access to the benefits of this unique therapeutic, regardless of the way their clinic generates bicarbonate. Clinicians will now have the added flexibility to administer Triferic intravenously to a broader group of patients who can benefit from physiologic iron maintenance therapy to manage their anemia,” stated Stuart Paul, President and Chief Executive Officer of Rockwell Medical.