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Takeda Pharmaceutical Co said last Wednesday it had applied for approval to market in the United States the DPP-4 inhibitor Alogliptin and the Actos diabetes drugs in a single tablet for the treatment of type 2 diabetes.
Takeda is currently waiting for U.S. approval of alogliptin a DPP-4 inhibitor, a successor candidate for its best-selling Actos which will lose patent protection in the world’s largest drug market in 2011.
"It is the world’s first drug combining alogliptin and pioglitazone (the generic name of Actos). Takeda made the application for the combination drug on Sept 19 and expects to receive approval in about 10 months at the earliest, she said. Takeda applied for FDA approval for its Alogliptin last January.
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. The only other DPP-4 inhibitor in the market is Januvia.
The NDA submission was supported by six Phase 3 clinical trials involving over 2,000 patients conducted in 220 centers worldwide. The safety and efficacy of alogliptin was studied as a once-daily monotherapy adjunct to diet and exercise and as an add-on therapy to other antidiabetic medications including sulfonylureas, metformin, thiazolidinediones (TZDs), and insulin. In the studies, alogliptin was associated with statistically significant reductions in hemoglobin A1c, which reflects average blood glucose concentration over the previous two to three months. Alogliptin was well-tolerated and weight neutral. There was no increase in hypoglycemia compared to placebo.
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.
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