JW Pharmaceutical said on Friday that its oral renal anemia drug, Enaroy (ingredient: enarodustat), obtained license approval from the Ministry of Food and Drug Safety (MFDS).
Renal anemia is one of the complications of chronic kidney disease, and is caused by poor differentiation and proliferation of red blood cells due to lack of erythropoietin from kidney dysfunction. The lack of oxygen supply due in the red blood cells decreases energy production in thus impacting the quality of life and even mortality.
Accordingly, Enaroy is a new drug to treat renal anemia in adult patients with chronic kidney disease undergoing hemodialysis. Particularly, it is a hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor that activates the production of erythropoietin, a hormone that promotes red blood cell production and improves hemoglobin levels.
Enaroy is available as an oral tablet formulation in 1mg, 2mg, and 4mg doses to enhance patient’s medication compliance.
JW Pharmaceutical signed a license agreement with Japan Tobacco in 2016 for the domestic development and copyright of the drug candidate JTZ-951. Subsequently, JW Pharmaceutical proved the effectiveness and safety of JTZ-951 through phase 3 cross-linking clinical trials at 28 hospitals in Korea and confirmed the non-inferiority of the existing treatment, darbepoethin alfa.
“We plan to launch this drug in Korea next year after consultation with the Health Insurance Review and Assessment (HIRA) service," a JW Pharmaceutical official said. “Enaroy is an oral treatment which we expect to be a new option for patients suffering with renal anemia.”