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New Possible DPP-4/TZD Combo for Jan 2012

Takeda announced that the FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of January 25, 2012 for the review of its investigational type 2 diabetes therapy alogliptin, and the fixed-dose combination therapy alogliptin/pioglitazone.

Currently, the FDA is reviewing the new drug applications (NDA) for the investigational therapies, which were resubmitted on July 25, 2011; the FDA has categorized these as Class 2 responses, requiring up to six months for review.Alogliptin is a selective dipeptidyl peptidase IV inhibitor (DPP-4i) under investigation in the United States (U.S.) for the treatment of type 2 diabetes as an adjunct to diet and exercise.Discovered by Takeda San Diego, Inc., alogliptin is designed to slow the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide), which play a role in regulating blood glucose levels. Pioglitazone was approved in 1999 for the treatment of type 2 diabetes as an adjunct to diet and exercise. Phase 3 studies have demonstrated that the combination of alogliptin with pioglitazone produced significant improvements in glycemic control, as compared to individual monotherapy. If approved, alogliptin/pioglitazone will be the first type 2 diabetes treatment option in the U.S. to include both a DPP-4 inhibitor and a thiazolidinedione (TZD) in a single tablet.

Common adverse events (greater than or equal to 5%) identified in the alogliptin phase 3 program included headache, urinary tract infection, nasopharyngitis, and upper respiratory tract infection. In the alogliptin/pioglitazone phase 3 program, the common adverse events (greater than or equal to 5%) identified included nasopharyngitis, back pain, urinary tract infection, and influenza.

Takeda Global Research & Development Center, Inc