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Takeda Resubmits New Drug Applications to the United States Food and Drug Administration for Alogliptin and the Fixed-Dose Combination Alogliptin and Pioglitazone
Date:7/27/2012

DEERFIELD, Ill. and OSAKA, Japan, July 27, 2012 /PRNewswire/ -- Takeda Pharmaceutical Company Limited (Takeda) announced today that its wholly-owned subsidiary, Takeda Global Research & Development Center, Inc., resubmitted New Drug Applications (NDAs) to the United States (U.S.) Food and Drug Administration (FDA) for alogliptin and fixed-dose combination (FDC) alogliptin and pioglitazone. Takeda anticipates that these applications will be reviewed within the next six months. These NDAs were resubmitted in response to the complete response letter Takeda received from the FDA, dated April 25, 2012.

"Takeda was able to respond to the FDA promptly with significant new data from our ongoing clinical trial program and updated postmarketing data from outside the U.S.," said David Recker, M.D., senior vice president, clinical science, Takeda Global Research & Development Center, Inc. "Based on our meeting with the FDA in late June, Takeda believes the information included in the NDA resubmissions for alogliptin and the fixed-dose combination alogliptin and pioglitazone will address the Agency's request for additional data, and these investigational therapies remain a top priority for the company."

This 2012 resubmission includes 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 selective dipeptidyl peptidase-4 inhibitor (DPP-4i) under investigation in the U.S. for the treatment of type 2 diabetes as an adjunct to diet and exercise. Alogliptin is designed to slow the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide), which play roles in r
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SOURCE Takeda Pharmaceutical Company Limited
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