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Japan : TENELIA 20mg tablets, a Treatment for Type 2 Diabetes Mellitus Approval of Partial Change in Indication to Lift Restrictions in Combination Therapy.

Mitsubishi Tanabe Pharma Corporation (hereafter, Mitsubishi Tanabe Pharma; President & CEO: Michihiro Tsuchiya) and Daiichi Sankyo Co., Ltd. (hereafter, Daiichi Sankyo; President & Representative Director: Joji Nakayama) announced today that Mitsubishi Tanabe Phama has received approval of a partial change in indication for TENELIAA 20mg tablets (generic name: Teneligliptin hydrobromide hydrate) for the treatment of type 2 diabetes mellitus.

Based on the approval of the partial change, the indication of TENELIAA has changed to type 2 diabetes mellitus based on the Guideline for Clinical Evaluation of Oral Hypoglycemic Agents , and TENELIAA is now available for combination therapy with existing oral hypoglycemic agents, such as biganides, ?-glucosidaseinhibitors, rapid-acting insulin secretagogues, and insulin preparations, as well as sulfonylureas and thiazolidines that had been approved for the combination.

TENELIAA is a DPP-4 (dipeptidyl peptidase-4) inhibitor created by Mitsubishi Tanabe Pharma and launched in September 2012 by both Mitsubishi Tanabe Pharma and Daiichi Sankyo through their strategic alliance to contribute to the treatment of diabetes in Japan. TENELIAA, with its potent and sustained action, has been proven highly effective in lowering the postprandial blood glucose levels, as well as fasting blood glucose levels, through once-a-day administration.

By providing this new treatment option for type 2 diabetes mellitus, Mitsubishi Tanabe Pharma and Daiichi Sankyo hope to provide further support for patients who are combating this disease.

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Publication:Mena Report
Date:Dec 21, 2013
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