Osaka, Japan, November 29, 2016 - Takeda Pharmaceutical Company Limited （TSE: 4502） （“Takeda”） today announced that Inisync® Combination Tablets, a fixed-dose combination of Nesina® （generic name: alogliptin benzoate） and metformin hydrochloride （hereinafter “metformin”）, is now available in Japan for the treatment of type 2 diabetes.
Inisync combination tablets combine 25 mg alogliptin and 500 mg metformin, which is orally administered once daily. Nesina is a once-daily dipeptidyl peptidase-IV （DPP-4） inhibitor*, and metformin is biguanide that inhibits sugar production in the liver administered twice or three times daily. Both of them are widely used as therapeutic drugs for the treatment of diabetes. Inisync is the only combination administered once daily of a DPP-4 inhibitor and metformin in Japan.
The approval for Inisync was granted based on the efficacy and safety data in the existing clinical studies related to Nesina and the Phase III study for Inisync in Japan in which the compounds of this combination, Nesina and metformin, were concomitantly administered.
“Pathology and treatment of type 2 diabetes are complex and the needs of patients and the treatment options have diversified.” said Masato Iwasaki, Ph.D., Director and President, Japan Pharma Business Unit of Takeda. “We have launched the once-weekly DPP-4 inhibitor, Zafatek, last year. We continue our efforts such that our newly launched product, Inisync combination tablets can be utilized as a new treatment option and we continue to contribute to healthcare professionals and patients in Japan through therapeutic drug advances for the treatment of diabetes.”
* A DPP-4 inhibitor enhances the insulin secretion based on the plasma glucose levels, and it controls the levels by selectively inhibiting DPP-4 activity that inactivates two hormones, the incretin hormones （gastrointestinal hormones that promote insulin secretion） that play important roles in adjusting blood glucose, glucagon-like peptide-1 （GLP-1） and glucose-dependent insulinotropic polypeptide （GIP）.
|Name of the product||Inisync® Combination Tablets|
|Generic Name||Alogliptin benzoate and metformin hydrochloride|
|Indication||Type 2 diabetes
However, administration is limited only when it is judged appropriate to treat it concomitantly with alogliptin benzoate and metformin hydrochloride.
|Dosage and administration||Usually, for adults, one tablet （25 mg/500mg as alogliptin benzoate/metformin hydrochloride） is orally administered once daily immediately before meals or after meals.|
|Drug price||Inisync® Combination Tablets: ￥174.20|
About Takeda Pharmaceutical Company
Takeda Pharmaceutical Company Limited is a global, R＆D-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its research efforts on oncology, gastroenterology and central nervous system therapeutic areas. It also has specific development programs in specialty cardiovascular diseases as well as late-stage candidates for vaccines. Takeda conducts R＆D both internally and with partners to stay at the leading edge of innovation. New innovative products, especially in oncology and gastroenterology, as well as its presence in emerging markets, fuel the growth of Takeda. More than 30,000 Takeda employees are committed to improving quality of life for patients, working with our partners in health care in more than 70 countries. For more information, visit http://www.takeda.com/news.
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