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 corporate Web site, www.takeda.com.

About Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc.

Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology and gastroenterology treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for diabetes, cardiovascular disease, gastroenterology, neurology and other conditions. To learn more about these Takeda companies, visit www.tpna.com.


'/>"/>
SOURCE Takeda Pharmaceutical Company Limited
Copyright©2009 PR Newswire.
All rights reserved

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:4/19/2017)... , Tenn. and DALLAS , April 19, ... Inc., announced that the first patients in ... EndoStim device in the Lower Esophageal Sphincter Stimulation for ... minimally-invasive implantable device designed to provide long-term reflux control ... GERD affects nearly 65 million people in ...
(Date:4/19/2017)... 19, 2017 Companion ... response in pets such as canine, avian and ... various types such as Attenuated Live Vaccines, Conjugate ... Vaccines and Recombinant Vaccines. Attenuated live vaccines are ... bacteria, which have been weakend under laboratory conditions. ...
(Date:4/19/2017)... , April 19, 2017  SARES•REGIS Group leased ... is developing at Conejo Spectrum Business Park in ... Atara Biotherapeutics, Inc. , a biopharmaceutical company ... life-threatening diseases that have been underserved by scientific ... therapies for cancer, autoimmune and infectious disease. ...
Breaking Medicine Technology:
(Date:4/28/2017)... , ... April 28, 2017 , ... ... expanded distribution of the GlycoMark test throughout the Northeast U.S. , GlycoMark ... patients with diabetes. The GlycoMark test provides a clinically proven one- to two-week ...
(Date:4/28/2017)... ... 2017 , ... Children and adolescents who enter the foster ... in the general population. That’s because foster care is designed to protect children ... no fault of their own, youth who have experienced trauma often have difficulty ...
(Date:4/28/2017)... ... April 28, 2017 , ... Bill Howe started his sewer and drain company ... Tina Howe joined the team, the Bill Howe brand was born and they began ... and giving back to the San Diego community in which they worked, lived and ...
(Date:4/28/2017)... ... April 28, 2017 , ... Woolsy Corporation ... supplements, through its Nova Skin Sciences division, recently announced the launch of Allumière ... with the power of an anti-aging concentrate. , Anogeissus Leiocarpa Bark ...
(Date:4/27/2017)... ... April 27, 2017 , ... ... respiratory hospital, based in Denver, Colorado, announced an agreement to create the Jane ... continuing support of the Jane and Leonard Korman Family Foundation. The collaboration leverages ...
Breaking Medicine News(10 mins):