Jeil Pharmaceutical said it has received marketing approval from the Ministry of Food and Drug Safety for Triferic (ingredient: sodium ferric citrate iron sulfate precipitation hydrate), an iron supplement.

The company received approval for Triferic as an iron supplement therapy for maintaining hemoglobin levels in adult patients with hemodialysis-dependent chronic renal failure.

Triferic, developed by Rockwell Medical, a U.S. pharmaceutical company, received approval from the U.S. Food and Drug Administration in March 2020 and is currently marketed in the U.S.

The hemodialysis guidelines of the Korean Society of Nephrology (KNA) recommend iron or erythropoietin-stimulating agents (ESA) for patients with iron deficiency anemia due to hemodialysis. However, there may be risks of cardiovascular disease and infection due to increased ferritin in the existing iron preparations.

Triferic can resolve such problems as an iron supplement therapy with a new mechanism that can immediately deliver iron to transferrin, a protein involved in the iron movement, and increases the productivity of hemoglobin and red blood cells without increasing iron storage.

“Through the new mechanism of Triferic, I believe it will be possible to reduce the use of hematopoietic hormones and iron drugs and improve the quality of life of hemodialysis patients,” according to a doctor who is a member of the Korean Society of Nephrology.

A Jeil company official also said, “The company expects Triferic will provide a mechanistic advantage to Korean hemodialysis patients by improving the paradigm of the existing iron supplementation therapy.”

Jeil plans to distribute Triperic is an ampoule form. After removing the ampoule cap, medical workers can administer the drug through a separate line during dialysis using a needle or syringe.