Takeda Submits Diabetes Combo NDA

Takeda‘s U.S. subsidiary, Takeda Global Research & Development Center, Inc., has submitted an NDA for alogliptin and Actos in a single tablet for the treatment of type 2 diabetes.

Alogliptin is a DPP-4 inhibitor; that class slows 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. 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. ACTOS is a thiazolidinedione (TZD) drug 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 is the originator of the TZD class of oral anti-diabetes medications.

“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 by two phase 3 clinical trials, involving more than 2,000 patients worldwide. The studies assessed the efficacy and safety of this therapy for the treatment of patients with type 2 diabetes not achieving glycemic targets with diet and exercise alone, or for patients uncontrolled on metformin. Study results showed that alogliptin/ACTOS produced significant improvements in glycemic control and measures of insulin resistance and beta-cell function.