The US Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for Triferic AVANU, an intravenous formulation of an existing treatment for the replacement of iron and maintenance of hemoglobin in hemodialysis patients.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.
The NDA was awarded to Rockwell Medical.
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 treatment delivers 5-7 mg of iron with every hemodialysis treatment to the bone marrow and maintains hemoglobin without increasing iron stores.Triferic donates iron immediately to transferrin when entered into the blood. The medication is then transported directly to the bone marrow to be incorporated into hemoglobin. All of the happens without an increase in ferritin.
Triferic Dialysate is designed to be administered through liquid bicarbonate, while the new formulation provides hemodialysis patients with greater access to the Triferic platform and expands administration options for clinicians.
"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.
"Clinical trials have demonstrated that patients treated with Triferic receive steady and consistent bioavailable iron to replace the iron that is lost at every dialysis treatment and hemoglobin is maintained. Now, even in clinics where delivering Triferic through the dialysate is not operationally possible, Triferic AVNU is an option. This may be especially important for patients who are difficult to manage, or for other special patient populations," added Dr. Steven Fishbane, Chief of Nephrology of Northwell Health and Professor of Medicine at the Zucker School of Medicine.