Triferic AVNU Approved for Iron Replacement and Hemoglobin Maintenance in Dialysis Patients

The FDA has approved the New Drug Application for Triferic AVNU®.

The Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Triferic AVNU® (ferric pyrophosphate citrate; Rockwell Medical), an intravenous formulation of Triferic for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease.

Triferic is an iron maintenance therapy that delivers between 5 to 7mg of iron with every hemodialysis treatment and maintains hemoglobin without increasing ferritin. Whereas Triferic Dialysate requires liquid bicarbonate for administration, Triferic AVNU is designed for direct intravenous infusion, regardless of a dialysis center’s mode of bicarbonate delivery.  

“Now, even in clinics where delivering Triferic through the dialysate is not operationally possible, Triferic AVNU is an option,”  said Dr Steven Fishbane, Chief of Nephrology of Northwell Health and Professor of Medicine at the Zucker School of Medicine. “This may be especially important for patients who are difficult to manage, or for other special patient populations.”

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The Company expects to launch Evaluation Programs during the third quarter of 2020 to allow clinics to gain direct experience with Triferic AVNU. The product is expected to be available commercially following the completion of the initial Evaluation Programs.

Triferic Dialysate is currently available in ampules and packets.

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