Furiex Pharmaceuticals confirmed that Takeda has resubmitted New Drug Applications (NDAs) to the FDA for alogliptin and fixed-dose combination therapy alogliptin/pioglitazone for the treatment of type 2 diabetes in adults. These NDAs were resubmitted in response to a complete response letter Takeda received from the FDA on April 25, 2012.
These 2012 resubmissions include additional data from three Phase 3 clinical trials involving more than 3,275 patients conducted at 1,384 centers worldwide. When combined with previously submitted Phase 3 clinical data, which included more than 8,000 patients conducted in more than 1,000 centers worldwide, nearly 10,000 patients have been treated with alogliptin in the clinical development programs to date.
Alogliptin is a DPP-4 inhibitor being investigated as an adjunct to diet and exercise for the treatment of type 2 diabetes. DPP-4 inhibitors address insulin deficiency by slowing the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide). As a result, an increased amount of active incretins enables the pancreas to secrete insulin in a glucose-dependent manner, thereby assisting in the management of blood glucose levels.
Pioglitazone (Actos; Takeda) is a thiazolidinedione that directly targets insulin resistance, a condition in which the body does not efficiently use the insulin it produces to control blood glucose levels. It is currently approved for use in adults for the treatment of type 2 diabetes as an adjunct to diet and exercise.
For more information call (919) 456-7814 or visit www.furiex.com.