Takeda Submits a New Drug Application in the U.S. for Alogliptin (SYR-322) / ACTOS(R) (pioglitazone HCl) for the Treatment of Type ...( OSAKA Japan Sept. 23 /- Takeda Ph...),Health

OSAKA, Japan, Sept. 23 /PRNewswire/ -- Takeda Pharmaceutical Company Limited (Takeda) announced today 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(R) (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 inhibitors slow the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic polypeptide). 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.

"Alogliptin/ACTOS, if approved, will be the first type 2 diabetes treatment option which includes a DPP-4 inhibitor and a TZD," said Yasuchika Hasegawa, President of Takeda. "Given the increased global incidence of type 2 diabetes and the need for new treatment options, we will strive to provide alogliptin/ACTOS, as a potentially important treatment option, to patients and healthcare providers."

The NDA submission was supported
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