Nesina

Treatment for Diabetes Type 2

Update: Nesina (alogliptin) Now FDA Approved - January 25, 2013

New Action Date for Alogliptin NDA

Takeda Receives New Action Date for Alogliptin (SYR-322) NDA

OSAKA, Japan, December 24, 2008 - Takeda Pharmaceutical Company Limited ("Takeda") today announced that Takeda Global Research and Development Center, Inc., a wholly owned United States (U.S.) subsidiary received notification that the U.S. Food and Drug Administration (FDA) will respond to the alogliptin New Drug Application (NDA) by June 26, 2009.

In October 2008, Takeda received notification from the FDA that it was unable to complete its review of the alogliptin NDA by the original Prescription Drug User Fee Act (PDUFA) date — October 27, 2008 — due to internal resource constraints. The FDA did not raise any issues with the data in the alogliptin NDA at that time.

Alogliptin which was discovered by Takeda’s wholly owned U.S. subsidiary, Takeda San Diego, Inc. is a dipeptidyl peptidase IV (DPP-4) inhibitor being reviewed as an adjunct to diet and exercise for the treatment of type 2 diabetes. Alogliptin. In December 2007, Takeda submitted its NDA for alogliptin to the FDA.

About DPP-4 Inhibitors

DPP-4 inhibitors inhibit the enzyme dipeptidyl peptidase IV (DPP-4), which metabolizes the insulin-increasing hormones glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP). By maintaining the blood levels of GLP-1 and GIP, DPP-4 inhibitors are a newer type of oral anti-diabetic with a novel mechanism of action for lowering blood sugar levels.

GLP-1 and GIP are secreted by the digestive tract following food intake, and stimulate the beta cells in the pancreas—thereby stimulating increased insulin secretion—and it has the potential to improve pancreatic beta-cell function. Furthermore, it is known that because GLP-1 suppresses glucagon secretion from the pancreas, the production of sugar in liver cells is also suppressed.

About Takeda Pharmaceutical Company Limited

Located in Osaka, Japan, Takeda (TSE:4502) is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products.

Posted: December 2008

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