Takeda Pharmaceutical Company Limited ("Takeda") announced that an additional indication for "NESINA®" (generic name: Alogliptin), combination therapy with thiazolidinediones for type 2 diabetes, was approved by the Japanese Ministry of Health, Labour and Welfare.

NESINA, a dipeptidyl peptidase-IV (DPP-4) inhibitor created by Takeda San Diego, Inc., Takeda's wholly-owned subsidiary, became available on the Japanese market in June 2010. It exhibits extremely high selectivity for DPP-4 inhibition, and a once daily dose with NESINA provides outstanding hypoglycemic benefits. NESINA slows the inactivation of the incretin hormones GLP-1 (glucagon-like peptide-1) which plays a major role in regulating blood glucose levels and the products has the potential to improve pancreatic beta-cell function.

NESINA is the only DPP-4 inhibitor that is approved for administration combined with alpha-glucosidase inhibitors in Japan, and the approval this time gives the option of combining DPP-4 with thiazolidinediones. Thiazolidinediones reduce insulin resistance, one of the pathologic conditions specifically found in type 2 diabetes, and Actos® (generic name: Pioglitazone) is the only approved thiazolidinedione in Japan marketed by Takeda. This additional indication of combination therapy is expected to improve two major pathologic conditions associated with type 2 diabetes: a decrease in insulin secretion and insulin resistance. Hence, this will provide a broader range of treatment options for diabetic patients and healthcare professionals.

Takeda will continue to increase its lineup of antidiabetes agents with different mechanisms of action and maximize the product value of each agent so that the best possible treatment option can be provided to patients, according to their individual condition, and hence make a more significant contribution to diabetic care.

For patients in whom the following treatments provide inadequate glycemic control:

1.Treatment by diet and exercise only

2.In addition to treatment by diet and exercise, treatment with an alpha-glucosidase inhibitor

3.In addition to treatment by diet and exercise, treatment with thiazolidinedione (Underlined portion indicates the scope of the additional indication approved.)

Dosage and Usage

NESINA is orally administered to adults once daily as Alogliptin 25mg.

Source: Takeda Pharmaceutical Company