Navigation Links
Takeda Receives FDA Complete Response Letter for Alogliptin, an Investigational Treatment for Type 2 Diabetes
Date:6/26/2009

DEERFIELD, Ill., June 26, and OSAKA, Japan, June 27, 2009 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda") today announced that Takeda Global Research & Development Center, Inc., a wholly owned United States (U.S.) subsidiary received on June 26 (U.S. time) a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the Company's New Drug Application (NDA) for alogliptin, a selective dipeptidyl peptidase IV (DPP-4) inhibitor under investigation for the treatment of type 2 diabetes as an adjunct to diet and exercise. In recent months, the FDA and Takeda have been in discussions about conducting an additional cardiovascular study for alogliptin.

As previously announced on March 6, 2009, the FDA informed Takeda that, although the alogliptin NDA was filed prior to the release of the December 2008 FDA Guidance titled, "Guidance for Industry: Diabetes Mellitus -- Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes," the FDA did not believe that the amount of existing alogliptin clinical data was sufficient to meet certain statistical requirements outlined in that Guidance. The FDA has asked Takeda to conduct an additional cardiovascular safety trial that satisfies the December 2008 FDA Guidance.

"Takeda will continue to promote key initiatives in order to realize sustained growth from a medium- to long-term perspective," said Takeda President & CEO, Yasuchika Hasegawa.

About Takeda Pharmaceutical Company Limited

Located in Osaka, Japan, Takeda 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 co
'/>"/>

SOURCE Takeda Pharmaceutical Company Limited
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2

Related medicine technology :

1. Takeda Submits New Drug Application for Alogliptin (SYR-322) in the U.S.
2. Takeda Doses First Patient in a U.S. Phase 1 Study of Hematide(TM) to Treat Chemotherapy Induced Anemia
3. Takeda Submits a New Drug Application in the U.S. for Alogliptin (SYR-322) / ACTOS(R) (pioglitazone HCl) for the Treatment of Type 2 Diabetes
4. Takedas Investigational PPI TAK-390MR Demonstrated Higher Healing Rates Compared to Lansoprazole as the Severity of Erosive Esophagitis Grade Increased, a New Integrated Analysis Showed
5. Amgen, Takeda and Millennium Provide Update on Phase 3 Trial of Motesanib in Patients With Non-Small Cell Lung Cancer
6. Takeda Initiates Two Phase III Studies with Vedolizumab (MLN0002) in Patients with Inflammatory Bowel Disease
7. Takeda to Revise Timing of Alogliptin and Alogliptin/ACTOS MAA Filings in Europe
8. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
9. Indevus Receives Approvable Letter From FDA for VALSTAR(R) for Bladder Cancer Therapy
10. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
11. Abbott Receives Supplemental FDA Approval for its Best-in-Class in Sensitivity RealTime HIV-1 Viral Load Test
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/25/2014)... BERWYN, Pa. , July 25, 2014  AMETEK, ... appointment of Kurtis L. Goos as Vice ... Engineered Materials, Interconnects and Packaging (EMIP) Division. ... has extensive general management and business development experience, especially ... to make important contributions to the continued growth and ...
(Date:7/25/2014)... NORTH CHICAGO, Ill., July 25, 2014 ... PART, DIRECTLY OR INDIRECTLY, IN, INTO OR FROM ANY JURISDICTION ... RELEVANT LAWS OR REGULATIONS OF SUCH JURISDICTION AbbVie (NYSE: ... quarter ended June 30, 2014. "This was ... and earnings per share above our original guidance and announced ...
(Date:7/24/2014)... , July 24, 2014   AcelRx Pharmaceuticals, Inc. ... focused on the development and commercialization of innovative therapies ... confirmed the PDUFA date for Zalviso remains July 27, ... rumor circulated online stating the Food and Drug Administration ... there has been no notification to the company from ...
Breaking Medicine Technology:AMETEK Names Kurtis L. Goos, Vice President & General Manager, Engineered Medical Components 2AbbVie Reports Second-Quarter 2014 Financial Results 2AbbVie Reports Second-Quarter 2014 Financial Results 3AbbVie Reports Second-Quarter 2014 Financial Results 4AbbVie Reports Second-Quarter 2014 Financial Results 5AbbVie Reports Second-Quarter 2014 Financial Results 6AbbVie Reports Second-Quarter 2014 Financial Results 7AbbVie Reports Second-Quarter 2014 Financial Results 8AbbVie Reports Second-Quarter 2014 Financial Results 9AbbVie Reports Second-Quarter 2014 Financial Results 10AbbVie Reports Second-Quarter 2014 Financial Results 11AbbVie Reports Second-Quarter 2014 Financial Results 12AbbVie Reports Second-Quarter 2014 Financial Results 13AbbVie Reports Second-Quarter 2014 Financial Results 14AbbVie Reports Second-Quarter 2014 Financial Results 15AbbVie Reports Second-Quarter 2014 Financial Results 16AbbVie Reports Second-Quarter 2014 Financial Results 17AbbVie Reports Second-Quarter 2014 Financial Results 18AbbVie Reports Second-Quarter 2014 Financial Results 19AbbVie Reports Second-Quarter 2014 Financial Results 20AbbVie Reports Second-Quarter 2014 Financial Results 21AbbVie Reports Second-Quarter 2014 Financial Results 22AbbVie Reports Second-Quarter 2014 Financial Results 23AbbVie Reports Second-Quarter 2014 Financial Results 24AbbVie Reports Second-Quarter 2014 Financial Results 25AbbVie Reports Second-Quarter 2014 Financial Results 26AbbVie Reports Second-Quarter 2014 Financial Results 27AbbVie Reports Second-Quarter 2014 Financial Results 28AbbVie Reports Second-Quarter 2014 Financial Results 29AbbVie Reports Second-Quarter 2014 Financial Results 30AbbVie Reports Second-Quarter 2014 Financial Results 31AbbVie Reports Second-Quarter 2014 Financial Results 32AbbVie Reports Second-Quarter 2014 Financial Results 33AbbVie Reports Second-Quarter 2014 Financial Results 34AbbVie Reports Second-Quarter 2014 Financial Results 35
... 5, 2011 meridianEMR, the market leader in EHR ... Somerville, New Jersey was the first meridianEMR customer to ... Centers for Medicare and Medicaid Services (CMS). On July ... $54,000 for three physicians via direct deposit. The group ...
... Biotech Ltd. (Nasdaq: SVA ), a leading ... of Jacob Chik Keung Ho, its Chief Financial Officer, for ... a new Chief Financial Officer to replace Mr. Ho, who ... 2011.  Ms. Nan Wang, Vice President of Sinovac, has been ...
Cached Medicine Technology:meridianEMR® Customers Start Receiving Meaningful Use Incentive Payments 2meridianEMR® Customers Start Receiving Meaningful Use Incentive Payments 3Sinovac Announces Management Changes 2Sinovac Announces Management Changes 3
(Date:7/25/2014)... Garth Brooks Chicago tickets go on sale Friday, ... Garth Brooks was one of the leaders on the country ... 1989. Since "Much Too Young (To Feel This Damn Old)" was ... Okl. native and in the years that he has been away ... stage and in the recording studio. Between 2001 and 2009, fans ...
(Date:7/25/2014)... 25, 2014 -- The Elizabeth Glaser Pediatric AIDS ... the Medicines Patent Pool (MPP) and Gilead Sciences, ... (TAF), a promising new HIV medication. The agreement ... (AIDS 2014) in Melbourne, Australia. , While ... early data suggests it could be a key ...
(Date:7/25/2014)... A report released by the Juvenile Diabetes ... 2013 (July 1, 2012- June 30, 2013). , Outside of ... is the largest single funder of type 1 diabetes research ... with most of the top research centers. There is ... 1 diabetes in the near future. , Since the 2008 ...
(Date:7/25/2014)... Mateo, CA (PRWEB) July 25, 2014 ... an upcoming episode of Innovations with Ed Begley Jr, ... and show times TBA. , For more than four ... the Bay Area community through its residential alcohol and ... will educate on Project Ninety's humble idea and how ...
(Date:7/25/2014)... 2014 Stwd.co.uk, one of the leading ... of cheap evening dress for women. In ... big promotion for these items. They are available at ... last until August 30. , “We are pleased to ... outfits, we have a large number of stylish special ...
Breaking Medicine News(10 mins):Health News:Garth Brooks Chicago Tickets for Performance at Allstate Arena in Rosemont Go On Sale July 25th 2Health News:Garth Brooks Chicago Tickets for Performance at Allstate Arena in Rosemont Go On Sale July 25th 3Health News:Report: JDRF 2013 Annual Research Spending Down by $50 million 2Health News:Project Ninety to be Featured on Innovations with Ed Begley, Jr. 2Health News:Project Ninety to be Featured on Innovations with Ed Begley, Jr. 3Health News:Famous Supplier Stwd.co.uk Announces Its New Selection of Evening Dresses for Women 2
... The number of airline mishaps attributed to pilot error ... analysis conducted by researchers at the Johns Hopkins Bloomberg ... airline mishaps remained stable during that time, the proportion ... rate of mishaps related to a pilots poor decision-making ...
... New Advice for Doctors About Low-Fat, Low-Carb Restricted ... 28 The American,Diabetes Association (ADA) today issued ... providers treat people with diabetes,using the most current ... occurs in the Medical Nutrition Therapy,section dealing with ...
... deprive them of rest needed for healing, study says ... patterns of intensive care unit (ICU) patients are so ... restorative phases of sleep that help promote healing, says ... Southwestern Medical Center at Dallas. , The study ...
... Eclipsys Corporation(R),(Nasdaq: ECLP ), The Outcomes ... 2008 JPMorgan Healthcare Conference taking place from,January 7th ... http://www.newscom.com/cgi-bin/prnh/20050209/FLW006LOGO ), Eclipsys executives will ... 3:00 p.m. Pacific time. To access the live ...
... The National Drug,Intelligence Center (NDIC), a ... nation,s principal center for strategic drug intelligence, ... This strategic,assessment presents an analysis of key ... and abuse in the,United States. The assessment ...
... SAN FRANCISCO, Dec. 27 OneMedPlace will hold its ... the Sir Francis Drake,Hotel in Union Square., This ... cap public,companies and early stage venture backed companies to ... both public and private, will present at,the conference and ...
Cached Medicine News:Health News:Pilot error declines as factor in airline mishaps 2Health News:ADA Issues New Clinical Practice Recommendations 2Health News:ADA Issues New Clinical Practice Recommendations 3Health News:ICU Patients Not Getting Enough Sleep 2Health News:Eclipsys to Present at JPMorgan Healthcare Conference 2Health News:Eclipsys to Present at JPMorgan Healthcare Conference 3Health News:National Drug Intelligence Center Releases 2008 National Methamphetamine Threat Assessment 2Health News:OneMedPlace Emerging Healthcare Technologies Finance Forum Jan 7, 8th 2
iSleep 20i is an advanced high performance CPAP with outstanding self-adjusting i‑technology....
Spectrum Dynamics empowers Nuclear Imaging with the SmartR Technology,of the D-SPECT Cardiac Imaging System. The D-SPECT is powered by BroadView Technology to provide unprecedented throughput, whil...
Diagnosoft HARP is designed for rapid analysis of tagged cardiac MR images using the HARP technology, which is packaged into an intuitive, easy-to-use graphic user interface....
... accurately differentiates clinically significant progression of ... providing an advanced, proven method to ... patients. , ,The software applies knowledge ... in which the actual test/retest variability ...
Medicine Products: