Application for Additional Dosage Form of CANALIA® Combination OD Tablets, Selective DPP-4 inhibitor/SGLT2 inhibitor Combination Drug

1/1 February 20, 2024 Application for Additional Dosage Form of CANALIA® Combination OD Tablets, Selective DPP-4 inhibitor/SGLT2 inhibitor Combination Drug Today, Mitsubishi Tanabe Pharma Corporation (Head Office: Chuo-ku, Osaka; Representative Director: Akihiro Tsujimura; hereinafter, "MTPC"), a member of the Mitsubishi Chemical Group, submitted to the Ministry of Health, Labour and Welfare of Japan an application for an additional dosage form of CANALIA® Combination OD Tablets, which is orally disintegrating tablets (OD tablets) for CANALIA® Combination Tablets, the combination drug of selective DPP-4 inhibitor and SGLT2 inhibitor. CANALIA® Combination Tablets were approved as the first combination drug composed of a DPP-4 inhibitor and a SGLT2 inhibitor in Japan and were launched in September 2017 as a treatment for type 2 diabetes mellitus. Teneligliptin (product name: TENELIA® Tablets), a selective DPP-4 inhibitor, and canagliflozin (product name: CANAGLU® Tablets), an SGLT2 inhibitor, are included in CANALIA® Combination Tablets. Teneligliptin and canagliflozin are type 2 diabetes treatment drugs originally discovered by MTPC in Japan. CANALIA® Combination Tablets, which contains the above two active ingredients, has two different mechanisms of action: a DPP-4 inhibitor stimulates insulin secretion according to blood glucose levels, and a SGLT2 inhibitor promotes glucose excretion into urine. As a result, it is expected to achieve good glycemic control with one tablet once daily. Since the launch, it has been used to improving the convenience of patients receiving concomitant treatment with TENELIA® Tablets and CANAGLU® Tablets and the glycemic control of patients who had an inadequate response to monotherapy with TENELIA® Tablets or CANAGLU® Tablets. On the other hand, OD tablets, which easily disintegrate with a small amount of water, are quickly soluble in water such as saliva in the mouth, and can be taken without or with water without depending on the place. It is expected to improve convenience and to continue taking the drug for people with type 2 diabetes mellitus who need continuous treatment. MTPC started to sell “TENELIA® Tablets” as OD tablets in June 2021. “TENELIA® OD Tablets” is the only OD tablet of a selective DPP-4 inhibitor in Japan at present. In March 2023, we filed an application for approval of an additional OD tablet formulation for CANAGLU® Tablets. MTPC will continue working to deliver the new treatment options for people living with type 2 diabetes to enhance satisfaction with treatment and convenience. Contact: Mitsubishi Chemical Group Corporation Corporate Communications Division Osaka Corporate Communications Department +81-6-6205-5119

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