Benzinga | Feb 9, 2021 07:04AM EST

Rockwell Medical Announces U.S. Availability of Triferic AVNU for Replacement of Iron and Maintenance of Hemoglobin in Patients on Hemodialysis

Rockwell Medical, Inc. (NASDAQ:RMTI), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia management and improving outcomes for patients around the world, today announced that Triferic AVNU (ferric pyrophosphate citrate injection), the intravenous (IV) formulation of Triferic, is now available to patients in the United States. Triferic AVNU was approved by the U.S. Food and Drug Administration (FDA) in March 2020 and is indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD).

"The commercial availability of Triferic AVNU is good news for patients with chronic kidney disease on hemodialysis and their healthcare providers. This IV formulation is an important line extension of Triferic Dialysate," said Russell Ellison, M.D., M.Sc., President and Chief Executive Officer of Rockwell Medical. "With Triferic AVNU, more patients will have access to the benefits of Triferic as providers will have added flexibility to administer the IV formulation to their patients who may benefit from physiologic iron maintenance therapy to manage their anemia."

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 IV 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 online dialysate generation, which is not compatible with Triferic Dialysate.

Triferic AVNU is available for commercial purchase directly through Rockwell Medical and our exclusive distributor, Metro Medical(tm), a Cardinal Health company, to expand market availability and ease of ordering. Metro Medical has a long history as a leading distributor of pharmaceuticals and medical supplies to nephrology practices and clinic-based dialysis centers in the U.S., the focus market for Triferic ANVU.