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Thursday, September 25, 2008

Takeda : New Drug Application in the U.S. for Alogliptin (SYR-322) / ACTOS(R) (pioglitazone HCl) for the Treatment of Type 2 Diabetes

September 24, 2008 - Takeda Pharmaceutical Company Limited (Takeda) announced that its wholly owned subsidiary, Takeda Global Research & Development Center Inc. (U.S.), submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of alogliptin (SYR-322) and ACTOS® (pioglitazone HCl) (“alogliptin/ACTOS”) in a single tablet for the treatment of type 2 diabetes.

Alogliptin was discovered by Takeda’s wholly owned subsidiary, Takeda San Diego, Inc. and is a member of the DPP-4 inhibitors class, which are newer oral agents for the treatment of type 2 diabetes. DPP-4 inihibitors slow the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide). The incretins play a major role in regulating blood glucose levels and have the potential to improve pancreatic beta-cell function. GLP-1 and GIP are produced by the digestive tract in response to food and regulate glucose balance, primarily by stimulating glucose-dependent insulin secretion. In addition, GLP-1 suppresses pancreatic glucagon secretion and subsequent liver glucose production, enhances glucose disposal, slows gastric emptying, and elicits satiety, a feeling of fullness. Takeda is the originator of the thiazolidinedione (TZD) class of oral anti-diabetes medications. ACTOS is a TZD that directly targets insulin resistance, a condition in which the body does not efficiently use the insulin it produces to control blood glucose levels... Takeda's Press Release -