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Japanese MMA for Mitsubishi's diabetes drug

09 July 2014 | Regulatory | By BioSpectrum Bureau

Mitsubishi Tanabe Pharma will manufacture and market Canaglu, and co-promote it with Daiichi Sankyo

Mitsubishi Tanabe Pharma will manufacture and market Canaglu, and co-promote it with Daiichi Sankyo

Singapore: Mitsubishi Tanabe Pharma and Daiichi Sankyo have announced that Mitsubishi Tanabe Pharma has received approval to manufacture and market the SGLT2 inhibitor, Canaglu tablets (canagliflozin hydrate) 100 mg in Japan, for the treatment of patients with type 2 diabetes mellitus.

Originating in Japan, Canaglu is an SGLT2 inhibitor. 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.

The company said in a statement that 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.

The statement added that 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.

Mitsubishi Tanabe Pharma will manufacture and market Canaglu, and co-promote it with Daiichi Sankyo, it said. Both the companies said in a news statement that by providing this new treatment option for type 2 diabetes mellitus, they hope to contribute to the treatment of individual patients.

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