FDA Will Not Be Able To Complete Its Review Of Takeda Pharmaceutical Co. Ltd.'s (JOBS) Alogliptin (SYR-322) NDA By The Prescription Drug User Fee Act (PDUFA) Date Of October 27, 2008; Delay Puts PPD, Inc. Payment On Hold
FDA Continues Review of Takeda's New Drug Application for Alogliptin (SYR-322), a DPP-4 Agent for Type 2 Diabetes
OSAKA, Japan, Oct. 10 /PRNewswire/ -- 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 not be able to complete its review of the alogliptin New Drug Application (NDA) by the Prescription Drug User Fee Act (PDUFA) date of October 27, 2008.
"In our most recent discussion with the FDA, it indicated that due to internal resource constraints it will not be able to complete the alogliptin review by the PDUFA date," said Dean Sundberg, senior vice president, regulatory affairs at Takeda Global Research and Development Center, Inc. "Additionally, the FDA did not provide Takeda with any guidance on when a review might be completed nor did it raise any issues with the data in the alogliptin NDA. Takeda remains confident in alogliptin's potential as a new treatment option for people suffering from type 2 diabetes and we will work with the FDA as they continue this NDA review."
Alogliptin is a dipeptidyl peptidase IV (DPP-4) inhibitor discovered by Takeda's wholly owned U.S. subsidiary, Takeda San Diego, Inc. In December, 2007 Takeda submitted its NDA for alogliptin for the treatment of type 2 diabetes. This submission enhances Takeda's position as a global leader in type 2 diabetes - one of Takeda's core therapeutic areas.
The alogliptin NDA submission included six Phase 3 clinical trials involving more than 2,000 patients conducted in 220 centers worldwide. The safety and efficacy of alogliptin was studied as a once-daily monotherapy adjunct to diet and exercise and as an add-on therapy to other antidiabetic medications including sulfonylureas, metformin, thiazolidinediones (TZDs), and insulin. In the studies, alogliptin was associated with statistically significant reductions in hemoglobin A1c, which reflects average blood glucose concentration over the previous two to three months. Alogliptin was generally well-tolerated and weight neutral. There was no increase in hypoglycemia compared to placebo.
About DPP-4 Inhibitors
DPP-4 inhibitors inhibit the enzyme dipeptidyl peptidase-4 (DPP-4), which selectively 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 new type of oral anti-diabetic with a novel mechanism of action for lowering blood sugar levels. GLP-1 and GIP are excreted in the digestive tract following food intake, and stimulate the beta-cells in the pancreas --- thereby stimulating increased insulin secretion --- and it has also been confirmed that they improve the functioning of the beta cells themselves. Furthermore it is known that because GLP-1 suppresses glucagon secretion from the pancreas, the production of sugar in liver cells is also suppressed and appetite is suppressed as well.
About Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda (TSE:4502 - News) 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. Additional information about Takeda is available through its corporate website, www.takeda.com.
Source: Takeda Pharmaceutical Company Limited