Riona® Tablets 250mg for the treatment of hyperphosphatemia approved in Japan
Tokyo, January 17, 2014 --- Japan Tobacco Inc. (JT) (TSE:2914) and Torii Pharmaceutical Co., Ltd. (Torii) (TSE:4551) announced today that JT has received manufacturing and marketing approval of Riona® Tablets 250mg, jointly developed by JT and Torii, from the Japanese Ministry of Health, Labour and Welfare. The drug is indicated as an oral treatment for the improvement of hyperphosphatemia in patients with chronic kidney disease (CKD).
Riona® Tablets is a novel phosphate binder containing ferric citrate hydrate as the active pharmaceutical ingredient. This new agent binds to phosphate in the gastrointestinal tract and decreases serum phosphorus concentration through inhibiting phosphate absorption into the body. Clinical efficacy in the decrease of serum phosphorus concentration was proven in Phase 3 studies, in both on dialysis and not on dialysis CKD patients with hyperphosphatemia in Japan. Furthermore, no clinically significant findings on the safety and tolerability of Riona® Tablets were observed in the long-term administration studies.
JT and Torii expect Riona® Tablets to become a new therapeutic option for hyperphosphatemia in patients with CKD, including dialysis and non-dialysis dependent CKD. Following its inclusion in the National Health Insurance (NHI) price list, Riona® Tablets will be sold exclusively by Torii in Japan. The drug’s launch date will be announced as soon as a decision is made.
Outline of approval
Product Name: Riona® Tablets 250mg