Navigation Links
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) 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,

SOURCE Takeda Pharmaceutical Company Limited
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Investment and Growth in US Medical Technology Industry Continues Despite Challenging Public Markets
2. Use of Biologic Agents Continues to Expand Among US Rheumatologists - Can New Agents Shift the Treatment Paradigm in Rheumatoid Arthritis?
3. Cequent Pharmaceuticals Meets Novartis Option Fund Milestone; Continues to Next Phase to Validate Inflammatory Bowel Disease Targets in Vivo
4. China-Biotics, Inc. Continues to Broaden Bulk Additives Client Base
5. InstaCare Corp. Continues Turnaround & Reports 291% Revenues Increase in 2Q 2008
6. The Quigley Corporation Reports Second Quarter 2008 Results: Continues Investment in Pharmaceutical R&D Future
7. Cystic Fibrosis - Axentis Pharma Takes Over Patents and Continues Development of Innovative Platform Technology
8. Gerresheimer Discontinues Marginal Operations
9. 3M Discontinues Collaboration with Gen-Probe to Develop Molecular Tests for Healthcare-Associated Infections
10. HDSA-San Diegos Team 2CureHD Continues its Race to Cure Huntingtons Disease
11. Tasty Baking Company Continues Partnership With Alexs Lemonade Stand Foundation To Fight Childhood Cancer
Post Your Comments:
(Date:11/24/2015)... 2015 --> ... released by Transparency Market Research, the global non-invasive prenatal ... of 17.5% during the period between 2014 and 2022. ... Industry Analysis, Size, Volume, Share, Growth, Trends and Forecast ... market to reach a valuation of US$2.38 bn by ...
(Date:11/24/2015)... ... November 24, 2015 , ... In harsh industrial ... points for in-line sensors can represent a weak spot where leaking process media ... of retractable sensor housings , which are designed to tolerate extreme process conditions. ...
(Date:11/24/2015)... Nov. 24, 2015 Capricor Therapeutics, Inc. ... on the discovery, development and commercialization of first-in-class therapeutics, ... Executive Officer, is scheduled to present at the 2015 ... 10:50 a.m. EST, at The Lotte New York Palace ... . --> ...
(Date:11/24/2015)... ... November 24, 2015 , ... Whitehouse Laboratories is pleased ... The new stand-alone facility will be strictly dedicated to basic USP 61, USP 62 ... clients the chance to have complete chemistry and micro testing performed by one supplier. ...
Breaking Biology Technology:
(Date:11/12/2015)... CAMBRIDGE, Mass. , Nov. 12, 2015 /PRNewswire/ ... Broad Institute of MIT and Harvard for use ... chemical discovery information management tools. The partnership will ... share both biological and chemical research information internally ... tools will be used for managing the Institute,s ...
(Date:11/10/2015)... 10, 2015  In this report, the ... of product, type, application, disease indication, and ... report are consumables, services, software. The type ... biomarkers, efficacy biomarkers, and validation biomarkers. The ... diagnostics development, drug discovery and development, personalized ...
(Date:11/9/2015)... 2015  Synaptics Inc. (NASDAQ: SYNA ), the ... entry into the automotive market with a comprehensive and ... of consumer electronics human interface innovation. Synaptics, industry-leading touch ... the automotive industry and will be implemented in numerous ... , Japan , and ...
Breaking Biology News(10 mins):