Triferic FDA Approved For Kidney Disease
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The Federal Food And Drug Administration (FDA) approved the drug Triferic on January 26, 2015. Triferic is an iron replacement drug which is used during dialysis to replace iron and maintain consistent hemoglobin levels as a major side effect of dialysis is iron-deficiency anemia. The final approval from the FDA allows Rockwell to proceed with the manufacture and distribution of Triferic to dialysis centers.
Triferic has been in development at Rockwell Medical Technologies in Wixom, Michigan. Rockwell is a small pharmaceutical company which is also producing Calcitriol which Rockwell will be launching in the near future. Ferric pyrophosphate citrate is the generic name for Triferic.
How Does Triferic Work?
Patients affected with kidney disease and end stage renal failure frequently contract iron-deficiency anemia as a side effect of the hemodialysis. Iron-deficiency anemia is common and occurs when red blood cells cannot carry enough oxygen throughout the blood stream. Iron is necessary to allow the red blood cells to sufficiently oxygenate the blood. Iron-deficiency anemia frequently causes tiredness and shortness of breath among other symptoms.
Currently patients on dialysis receive iron in a separate IV line to assist with maintaining appropriate iron levels. Triferic is not infused with an IV line, instead Triferic is added directly to the dialysis solution.
What Are The Implications For Patients?
Convenience and maintenance are two of the reported benefits of Triferic. Patients generally use dialysis three to five times a week and receive IV Iron in a separate intravenous line. Triferic allows a slow delivery method to the patient without overloading the patient with iron. Rockwell maintains this delivery method bypasses the liver to prevent an overload of iron. The goal is to prevent anemia caused by iron deficiency.
The clinical trials for all phases of the Triferic testing included 100,000 patients. One of the clinical trials involved testing Triferac over 52 weeks and hundreds of patients; the results of the that phase concluded that Triferic is a well tolerated therapy to Iron replacement and is a safe alternative to Iron replacement therapy due to risks associated with IV Iron replacement therapy.
Triferic is expected to be available in the next four to five months.
Triferic May 2015 Update
Four abstracts for kidney drug Triferic will be presented by the ERA-EDTA Congress for presentation May 28-31, 2015 in London, UK. The ERA-EDTA is a medical association which focuses on nephrology, renal issues and transplants and dialysis.