FDA Approves New Intravenous Triferic Formulation

The US Food and Drug Administration (FDA) has awarded 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.

The NDA, awarded to Rockwell Medical, means Triferic AVANU will join Triferic Dialysate as the only FDA-approved medication for this specific treatment in adults.

Triferic is a novel, physiologic iron maintenance therapy that provides bioavailable iron to replace the iron lost during every dialysis treatment, while maintaining hemoglobin.

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 new formulation can be administered regardless of a dialysis center’s mode of bicarbonate delivery because many centers in international markets and the US have converted to the use of dry bicarbonate cartridges or bags and online dialysis generation, which is not compatible with Triferic Dialysate.

“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,” Steven Fishbane, MD, Chief of Nephrology of Northwell Health and Professor of Medicine at the Zucker School of Medicine, said in a statement.