JW Pharmaceutical's Oral Anemia Treatment 'Enaroy Tablet' Approved by MFDS

[Asia Economy Reporter Lee Gwan-joo] JW Pharmaceutical announced on the 18th that it has obtained domestic product approval from the Ministry of Food and Drug Safety for the new anemia treatment drug "Enaroy Tablet" (active ingredient Enarodustat).

Enaroy Tablet is a new drug that treats anemia occurring in adult patients with chronic kidney disease undergoing hemodialysis. It is a hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor that activates the production of erythropoietin (EPO), a hormone that promotes red blood cell production, and reduces hepcidin, a hormone that regulates iron metabolism, thereby improving hemoglobin levels. It has been developed as an oral tablet formulation in three dosages of 1 mg, 2 mg, and 4 mg to enhance patient convenience.

In 2016, JW Pharmaceutical signed a license agreement with the Japanese company Japan Tobacco Inc. for the domestic development and sales rights of the new anemia drug candidate "JTZ-951." Subsequently, through Phase 3 bridging clinical trials conducted at 28 domestic hospitals, the efficacy and safety of JTZ-951 were demonstrated. Non-inferiority to the existing treatment "Darbepoetin Alfa" was also confirmed.

JW Pharmaceutical plans to launch Enaroy Tablet domestically next year after negotiations on insurance pricing with the Health Insurance Review and Assessment Service. A JW Pharmaceutical official stated, "Enaroy Tablet is an oral new anemia treatment drug that improves dosing convenience," and added, "We expect Enaroy Tablet to become a new option for patients suffering from anemia."

New anemia is a complication occurring in patients with chronic kidney disease, caused by erythropoietin deficiency due to impaired kidney function, which leads to poor differentiation and proliferation of red blood cells. The resulting oxygen supply shortage due to reduced red blood cells causes decreased energy production in organs, lowering daily activity levels, deteriorating quality of life, and significantly impacting mortality rates.

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