Marketing and manufacturing approval in Japan received for CANAGLU® tablets 100mg

Mitsubishi Tanabe Pharma Corporation (hereafter, Mitsubishi Tanabe Pharma; Head Office: Chuo-ku, Osaka; President & Representative Director, CEO: Masayuki Mitsuka) and Daiichi Sankyo Co., Ltd., (hereafter, Daiichi Sankyo; Head Office: Chuo-ku, Tokyo; Representative Director, President & CEO: Joji Nakayama) announced today that Mitsubishi Tanabe Pharma has received approval to manufacture and market the SGLT2 inhibitor, CANAGLU^® tablets 100mg (generic name: canagliflozin hydrate, hereafter, CANAGLU^®) in Japan, for the treatment of patients with type 2 diabetes mellitus.

CANAGLU^® is an SGLT2 inhibitor that originated in Japan. It is a treatment for type 2 diabetes mellitus which was discovered by Mitsubishi Tanabe Pharma and has its research roots in T-1095, the world’s first orally bioavailable sodium glucose co-transporter inhibitor. CANAGLU^® inhibits SGLT2, a transporter involved in the reabsorption of glucose in the renal tubules of the kidneys, suppresses the reabsorption of glucose, promotes the excretion of excessive glucose into the urine, and as a result, lowers the blood glucose level. 

More than 11,000 patients with type 2 diabetes were enrolled in global Phase 3 programs, including in Japan, which assessed the efficacy and safety of CANAGLU^®. The development program included a mono-therapy, dual and triple combination therapies with other anti-hyperglycemic agents and also involved type 2 diabetes patients with impaired renal function, patients who have or are at high risk of developing cardiovascular diseases and elderly patients. In March 2013, Janssen Pharmaceuticals, Inc. (Raritan, NJ, US), licensee, received approval for INVOKANA^® for the treatment of adult patients with type 2 diabetes mellitus in the US and, as of June 2014, has obtained approvals in more than 40 countries worldwide, including the US, Europe, Canada, and Australia.

Mitsubishi Tanabe Pharma will manufacture and market CANAGLU^®, and co-promote it with Daiichi Sankyo. By providing this new treatment option for type 2 diabetes mellitus, the two companies hope to contribute to the treatment of individual patients.