March 27, 2020

The U.S. FDA has approved Triferic AVNU® (ferric pyrophosphate citrate), manufactured by Rockwell Medical, to maintain hemoglobin by providing iron replacement for adults who have hemodialysis-dependent chronic kidney disease. The drug is a new intravenous (IV) formulation of previously FDA-approved Triferic®.

Hemodialysis is a procedure used to remove waste and water from the blood of individuals whose kidneys can no longer perform these functions properly. It requires the use of a dialysis machine and a filter known as an artificial kidney. During the process, the healthcare provider uses bicarbonate as a buffer to maintain a proper acid/base balance in the patient’s blood.

A novel iron maintenance therapy, Triferic and Triferic AVNU work by delivering bioavailable iron to the body. This iron replaces the iron lost during dialysis. In its original formulation, Triferic is designed for administration via liquid bicarbonate. However, many dialysis centers no longer use bicarbonate in a form compatible with this route of administration. Triferic AVNU is designed for administration via direct IV infusion, allowing for use independent of bicarbonate administration.

Each milliliter of Triferic AVNU contains 1.5mg of iron (III). Recommended dosing is 6.75mg iron (III) undiluted as a slow, continuous IV infusion over the course of three to four hours via pre-dialyzer infusion line, post-dialyzer infusion line, or a separate connection to the venous blood line during hemodialysis. Triferic ANVU should be given at each dialysis procedure for as long as the patient receives maintenance hemodialysis therapy for chronic kidney disease.

Rockwell Medical plans to make Triferic ANVU available in single-dose luer lock ampules via evaluation programs during the third quarter of 2020, with a commercial launch following the programs’ completion.

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