Navigation Links
FDA Continues Review of Takeda's New Drug Application for Alogliptin (SYR-322), a DPP-4 Agent for Type 2 Diabetes
Date:10/10/2008

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
'/>"/>

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

Page: 1 2

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:
*Name:
*Comment:
*Email:
(Date:5/21/2015)... , May 21, 2015  The EveryLife ... Hatch (R-UT) and Amy Klobuchar ... Now Accelerating Cures & Treatments, or OPEN ACT. ... disease patient advocacy organizations, this bipartisan legislation promises ... affordable medicines to rare disease patients by incentivizing ...
(Date:5/21/2015)... 2015 W. R. Grace & ... in Worms, Germany has received good manufacturing practice ... the International Pharmaceutical Excipient Council (IPEC) Foundation. ... its SYLOID® FP brand of pharmaceutical grade excipient ... the Curtis Bay, Maryland (USA) and Sorocaba, Brazil ...
(Date:5/21/2015)... LOS ANGELES , May 21, 2015 /PRNewswire/ ... research and development company specializing in oncology, today ... 2 clinical trial with aldoxorubicin for the treatment ... of brain cancer.  The open-label, multisite trial is ... of aldoxorubicin in patients whose tumors have progressed ...
(Date:5/21/2015)... DUBLIN , May 20, 2015 Research ... announced the addition of the "2015 Global ... to their offering. The primary goal ... of flow cytometry instruments and reagents. Key information ... drive the selection of flow cytometers, predominantly used ...
Breaking Biology Technology:Advocates Cheer Senate Leaders for Introducing Bipartisan Bill to Increase Number of Rare Disease Treatments 2Grace European Facility Receives GMP Excipient Certification for SYLOID® FP Silica Gel 2CytRx Reports Positive Updated Phase 2 Aldoxorubicin Clinical Trial Results in Glioblastoma Multiforme (Brain Cancer) 2CytRx Reports Positive Updated Phase 2 Aldoxorubicin Clinical Trial Results in Glioblastoma Multiforme (Brain Cancer) 3CytRx Reports Positive Updated Phase 2 Aldoxorubicin Clinical Trial Results in Glioblastoma Multiforme (Brain Cancer) 4CytRx Reports Positive Updated Phase 2 Aldoxorubicin Clinical Trial Results in Glioblastoma Multiforme (Brain Cancer) 5CytRx Reports Positive Updated Phase 2 Aldoxorubicin Clinical Trial Results in Glioblastoma Multiforme (Brain Cancer) 6CytRx Reports Positive Updated Phase 2 Aldoxorubicin Clinical Trial Results in Glioblastoma Multiforme (Brain Cancer) 7Global Survey on Flow Cytometry Adoption Trends 2015 2
... Mithridion , the University of Wisconsin-Madison spinoff developing a ... round of financing with $1.6 million, of which it has ... equipment, hiring scientists and developing drug candidates. , ,Trevor Twose, ... about 18 months, and that he may hire six people ...
... Madison, Wis. Third Wave Technologies is ... CEO transition, according to a press release. , ,Maneesh Arora, ... is filed. Arora has held senior positions in marketing and ... on. Gregory Hamilton, 35, will be vice president of finance. ...
... sent an announcement of pending Illinois broadband legislation (20 ... its synopsis: , Creates the Universal Access to Broadband ... (CMS) to create and maintain a map of broadband ... held broadband infrastructure shall be available for lease on ...
Cached Biology Technology:Mithridion raises $1.6M through angel networks 2Proposed Illinois broadband act falls short 2Proposed Illinois broadband act falls short 3Proposed Illinois broadband act falls short 4Proposed Illinois broadband act falls short 5
(Date:5/14/2015)... 2015  Verificient Technologies, Inc., a technology ... remote proctoring, announced a new alliance partnership ... creator of the Canvas Learning Management System ... will benefit from the seamless integration of ... a fully integrated multifactor biometrics behavioral application, ...
(Date:5/8/2015)... , May 8, 2015 Synaptics Inc. (NASDAQ: ... announced that members of the executive management team will present ... Annual Technology, Media and Telecom Conference Date: May 18, ... Boston, MA Cowen and ... Time: 2:45pm ET Location: The New York Palace Hotel, ...
(Date:4/27/2015)... 2015 NXT-ID, Inc. (NASDAQ: NXTD ) ... on the growing mobile commerce market, announces that its ... the first week of May, 2015 and will be ... Gino Pereira , Chief Executive ... company as Wocket® enters the consumer market. We would ...
Breaking Biology News(10 mins):Verificient and Instructure Announce Alliance Partnership to Provide Online Proctoring for K-12 and Higher Education Institutions 2Synaptics to Present at Upcoming Investor Conferences 2Wocket, the Smartest Wallet You Will Ever Own, Announces Shipment to Pre-order Customers 2Wocket, the Smartest Wallet You Will Ever Own, Announces Shipment to Pre-order Customers 3
... some 250 million years ago likely was accelerated by ... to a new study by a University of California, ... The researchers do not rule out the possibility ... in pathogenic soil bacteria that could devastate forests already ...
... LANSING, Mich. Most middle-schoolers struggle to grasp the ... crucial to advancing solutions to health problems and disease ... a Michigan State University researcher. In the journal ... heredity lessons should be taught with broader context and ...
... GTSI Corp. (NASDAQ: GTSI ), a leading ... governments, announced today the award of the Biometric Automated ... will provide war fighters mobile biometric devices to assist ... field. The contract has a total value of $159 ...
Cached Biology News:Did past climate change encourage tree-killing fungi? 2Did past climate change encourage tree-killing fungi? 3Michigan State scholar leads effort to reform genetics instruction 2GTSI Wins Department of Defense Contract to Provide Biometric Automated Toolset Systems for U.S. Army 2
...
...
... solid. An N-nitroso-containing diabetogenic compound that ... in pancreatic islets. An antibiotic effective ... and DNA strand breaks in pancreatic ... Soluble in H 2 O. RTECS ...
...
Biology Products: