Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd. announced that Japan Tobacco Inc. has received manufacturing and marketing approval for ENAROY Tablet 2 mg and 4 mg, a hypoxia inducible factor prolyl hydroxylase inhibitor, for an indication of anemia associated with chronic kidney disease in Japan. ENAROY is an orally-active HIF-PH inhibitor that promotes erythropoiesis by accelerating the endogenous production of erythropoietin and controlling the expression of molecules responsible for iron metabolism. The Phase 3 clinical studies confirmed the efficacy and safety of ENAROY in anemic patients with CKD not on dialysis, on peritoneal dialysis and on hemodialysis.

The JT and Torii expect ENAROY to be a new option for the treatment of anemia associated with CKD in Japan. Under the terms of the October 2017 agreement between the JT and Torii, the drug will exclusively be sold by Torii in Japan, following its inclusion in the National Health Insurance price list. The drugs' launch date will be announced as soon as a decision is made.

Outline of approval includes Dosage and Administration: For patients with CKD not on dialysis and on peritoneal dialysis. The recommended starting dose for adult patients is 2 mg taken orally once daily before a meal or at bedtime. Thereafter, the dose should be adjusted as appropriate depending on the patient's condition.

The maximum dose is 8 mg per dose. For patients with CKD on hemodialysis the recommended starting dose for adult patients is 4 mg taken orally once daily before a meal or at bedtime. Thereafter, the dose should be adjusted as appropriate depending on the patient's condition.

The maximum dose is 8 mg per dose.