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New Drug Application Approval of Zafatek® Tablets for the treatment of Type 2 Diabetes in Japan

March 26, 2015

Osaka, Japan, March 26, 2015 – Takeda Pharmaceutical Company Limited (“Takeda”) announced today that the Japanese Ministry of Health, Labour and Welfare has approved the New Drug Application of Zafatek®(generic name: trelagliptin succinate), a drug for treating type 2 diabetes.

Zafatek is a once-weekly DPP-4 (dipeptidyl peptidase-IV) inhibitor. It controls blood glucose levels by selectively and continually inhibiting DPP-4, an enzyme that causes the inactivation of glucagon-like peptide-1 and glucagon-dependent insulinotropic polypeptide, incretin hormones* that play an important role in blood glucose regulation. The inhibition of DPP-4 increases insulin secretion depending on blood glucose concentration, thereby controlling blood glucose levels.

The approval granted is based on the safety and efficacy results of multiple clinical phase III studies in patients with type 2 diabetes in Japan. The efficacy of once-weekly trelagliptin succinate was confirmed in all studies, in addition to a good safety and tolerability profile.

Takeda expects that it can provide a new treatment option with Zafatek, the world's first once-weekly DPP-4 inhibitor, and contribute to improvement in drug adherence and continued treatment of patients. The approval granted is a very important milestone for Takeda. Takeda will continue to deliver medicines which patients and healthcare professionals need and contribute to healthcare.

* An insulinotropic gastrointestinal hormone

 < Reference > 

Product Name Zafatek®
Generic Name trelagliptin succinate
Indications Type 2 diabetes
Dosage and administration Usually, for adults, 100 mg of trelagliptin is orally administered once a week