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Takeda Resubmits New Drug Applications in the U.S. for Investigational Type 2 Diabetes Therapies Alogliptin and the Fixed-Dose Combination Alogliptin/Pioglitazone
Date:7/25/2011

DEERFIELD, Ill. and OSAKA, Japan, July 25, 2011 /PRNewswire/  -- Takeda Pharmaceutical Company Limited (Takeda) announced today that Takeda Global Research & Development Center, Inc., resubmitted two New Drug Applications (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for alogliptin and the fixed-dose combination therapy alogliptin/pioglitazone, which combines alogliptin with pioglitazone in a single tablet. The FDA will review the NDA resubmissions within the next six months. Pioglitazone was approved in 1999 for the treatment of type 2 diabetes as an adjunct to diet and exercise. Alogliptin is a selective dipeptidyl peptidase IV inhibitor (DPP-4i) under investigation in the 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.

"We believe interim results from a cardiovascular outcomes trial satisfy the FDA's cardiovascular safety requirements to allow the Agency to complete its review of our NDA, and further support the product profile of alogliptin," said David Recker, M.D., senior vice president, clinical science, Takeda Global Research & Development Center. "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 in a single tablet."

The NDA resubmissions include interim results from the EXAMINE (EXamination of CArdiovascular OutcoMes: AlogliptIN vs. Standard of CarE in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome) study, a cardiovascular outcomes trial requested by the FDA to satisfy the criteria outlined in the December 2008 "Guidance for Industry
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SOURCE Takeda Pharmaceutical Company Limited
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