FDA delays review of Nesina (Takeda) for Type 2 Diabetes treatment

The FDA has announced that its review of investigational Type 2 Diabetes therapy Nesina (alogliptin), from Takeda, along with the fixed-dose combination therapy alogliptin/pioglitazone, will be delayed. The new Prescription Drug User Fee Act (PDUFA) action date has been set for April 25, 2012. The FDA originally assigned a PDUFA action date of January 25, 2012. Nesina is a highly potent and highly selective dipeptidyl peptidase IV inhibitor (DPP-4) under investigation in the US for the treatment of Type 2 Diabetes as an adjunct to diet and exercise. Alogliptin/pioglitazone combines two complementary agents with distinct mechanisms of action, and if approved, will be the first Type 2 Diabetes treatment option in the US to include both a DPP-4 inhibitor and a thiazolidinedione (TZD) in a single tablet.