Approval of Additional Indication of NESINA: Combination Therapy with Thiazolidinediones for Type 2 Diabetes in Japan

08-24-2010: Takeda Pharmaceutical Company Limited 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.