Benzinga | Jan 20, 2022 09:17AM EST

Rockwell Medical Announces Regulatory Approval Of Triferic Dialysate In South Korea

Two product forms of Triferic(r) are now approved in South Korea

WIXOM, Mich., Jan. 20, 2022 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia management worldwide, today announced that its partner in South Korea, Jeil Pharmaceutical Co., Ltd. ("Jeil"), has received a second regulatory approval by the Ministry of Food and Drug Safety of the Republic of Korea for Triferic(r) Dialysate (ferric pyrophosphate citrate sodium sulfate co-precipitate hydrate) for maintaining hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD).

"Chronic kidney disease continues to be a growing problem in South Korea, where Global comparative data shows that it ranks 4th in the world in prevalence of end-stage kidney disease1. This approval of Triferic Dialysate gives nephrologists another option for administration where needed to treat adult patients with HDD-CKD," said Marc Hoffman, M.D., Chief Medical Officer at Rockwell Medical. "Administration of Triferic ampules via dialysis concentrates has the potential to decrease nursing time needed to administer IV iron and may reduce patient-nurse contact time. This change in workflow may help manage the risk of disease spread in dialysis clinics, including COVID-19."

Rockwell Medical has an exclusive license agreement with Jeil for the rights to commercialize Triferic in South Korea. Under the terms of the license agreement, Jeil is the exclusive development and commercialization partner for both formulations under the Triferic brand in South Korea. Rockwell Medical will supply the product to Jeil.