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Takeda Announces PDUFA Action Date for Investigational Type 2 Diabetes Therapies Alogliptin and the Fixed-Dose Combination Alogliptin/Pioglitazone
Date:11/1/2011

DEERFIELD, Ill., Nov. 1, 2011 /PRNewswire/ -- Takeda Global Research & Development Center, Inc., (Takeda) announced that the U.S. Food and Drug Administration (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, which combines alogliptin with pioglitazone in a single tablet.  

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. 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.

According to the International Diabetes Federation, a staggering 285 million individuals were living with diabetes worldwide in 2010.

"As recent figures indicate that diabetes continues to be a serious global health challenge, Takeda remains deeply committed to researching new and important therapeutic options for patients living with type 2 diabetes," said David Recker, M.D., senior vice president, clinical science, Takeda Global Research & Development Center. "Phase 3 studies have demonstrated that the combination of a
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SOURCE Takeda Global Research & Development Center, Inc.
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