Japan marketing approval for Canaglu; vaccine license for Daiichi Sankyo

4 July 2014
daiichi-sankyo

Japanese drug major Mitsubishi Tanabe Pharma (TYO: 4508) has received approval to manufacture and market the SGLT2 inhibitor, Canaglu (canagliflozin hydrate) Japan, for the treatment of patients with type 2 diabetes mellitus.

Mitsubishi Tanabe, which discovered the compound that is already approved under the trade name Invokana being marketed by licensee US health care giant Johnson & Johnson (NYSE: JNJ) , will manufacture and market Canaglu, and co-promote it with fellow Japanese drugmaker Daiichi Sankyo (TYO: 4568). By providing this new treatment option for type 2 diabetes mellitus, the two companies hope to contribute to the treatment of individual patients.

More than 11,000 patients with type 2 diabetes were enrolled in global Phase III 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

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