Navigation Links
Takeda Receives New Information on Alogliptin (SYR-322) NDA
Date:3/6/2009

OSAKA, Japan, March 6 /PRNewswire/ -- Takeda Pharmaceutical Company Limited today announced that Takeda Global Research and Development Center, Inc., a wholly owned United States (U.S.) subsidiary, was informed as part of regular discussions about the alogliptin New Drug Application (NDA) with the United States Food and Drug Administration (FDA), that although the alogliptin NDA was filed prior to issuance of FDA's December 2008 guidance on new Type 2 diabetes treatments, the FDA will apply these guidelines when reviewing the alogliptin NDA.

Additionally, the FDA does not believe that the amount of existing alogliptin clinical data is sufficient to meet certain statistical requirements in the new guidance. The agency is open to discussions regarding the design of additional CV studies with alogliptin. Alogliptin's Prescription Drug User Fee Act (PDUFA) date - June 26, 2009 - remains unchanged.

In December, 2008 the FDA issued "Guidance for Industry: Diabetes Mellitus -- Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes".

In October 2008, Takeda received notification from the FDA that it was unable to complete its review of the alogliptin NDA by the original PDUFA date -- October 27, 2008 -- due to internal resource constraints. The FDA did not raise any issues with the data in the alogliptin NDA at that time. In December 2007, Takeda submitted its NDA for alogliptin to the FDA.

Alogliptin, which was discovered by Takeda's wholly owned U.S. subsidiary, Takeda San Diego, Inc. is a dipeptidyl peptidase IV (DPP-4) inhibitor being reviewed as an adjunct to diet and exercise for the treatment of type 2 diabetes.

About DPP-4 Inhibitors

DPP-4 inhibitors inhibit the enzyme dipeptidyl peptidase IV (DPP-4), which 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 newer type of oral anti-diabetic with a novel mechanism of action for lowering blood sugar levels.

GLP-1 and GIP are secreted by the digestive tract following food intake, and stimulate the beta cells in the pancreas--thereby stimulating increased insulin secretion--and it has the potential to improve pancreatic beta-cell function. Furthermore, it is known that because GLP-1 suppresses glucagon secretion from the pancreas, the production of sugar in liver cells is also suppressed.

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.


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

Related medicine news :

1. Healthcare Businesswomens Association Announces 2009 Woman of the Year, Dr. Deborah Dunsire, President and CEO of Millennium: The Takeda Oncology Company
2. Welvista Announces Partnering with Takeda to Provide Medication at No Cost to the Uninsured
3. Review of Takedas Febuxostat New Drug Application Continues Past PDUFA Date
4. FDA Adds Three Months to Review of Takedas New Drug Application for TAK-390MR
5. Takedas investigational PPI TAK-390MR demonstrated higher healing rates compared to lansoprazole
6. Takeda Completes Acquisition of Millennium
7. Takeda Commences Cash Tender Offer for all Outstanding Shares of Millennium
8. Takeda, Abbott Announce Plans to Conclude TAP Joint Venture
9. Takeda Announces New U.S. Leadership
10. Takeda submits new drug application for alogliptin (syr-322) in the US
11. Chemizon Announces Research Collaboration Expansion With Takeda
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... 2017 , ... Coveros, a leader in agile coaching services ... by the Center for Medicare and Medicaid Services (CMS). The Enterprise Agile Transformation ... Agile methodologies in a consistent and high value manner across CMS programs. Coveros ...
(Date:10/13/2017)... ... October 13, 2017 , ... “America On The Brink”: the ... “America On The Brink” is the creation of published author, William Nowers. Captain ... As a WWII veteran, he spent thirty years in the Navy. Following his ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... treating sleep apnea using cutting-edge Oventus O2Vent technology. As many as ... disorder characterized by frequent cessation in breathing. Oral appliances can offer significant relief ...
(Date:10/12/2017)... ... 2017 , ... The company has developed a suite of ... authorities worldwide. From Children’s to Adults 50+, every formula has been developed by ... , These products are also: Gluten Free, Non-GMO, Vegan, Soy Free, Non-Dairy*, Preservative ...
(Date:10/12/2017)... ... October 12, 2017 , ... The American College of Medical Informatics (ACMI) ... FACMI, during the Opening Session of AMIA’s Annual Symposium in Washington, D.C. AMIA’s ... Morris F. Collen, a pioneer in the field of medical informatics, this prestigious award ...
Breaking Medicine News(10 mins):
(Date:10/4/2017)... , Oct. 4, 2017  South Korean-based healthcare ... CPR training aide "cprCUBE" on Kickstarter. The device will ... during cardiac arrests with better efficiency compared to the ... offers real-time feedback on efficacy of the compression for ... campaign has a goal to raise $5,000. ...
(Date:10/2/2017)... , Oct. 2, 2017  Eli Lilly and Company ... results for the third quarter of 2017 on Tuesday, ... call on that day with the investment community and ... The conference call will begin at 9 a.m. ... access a live webcast of the conference call through ...
(Date:9/28/2017)... , Sept. 28, 2017 Hill-Rom Holdings, ... 2017 earnings conference call and webcast on Friday, November ... a.m. (EDT) and ending at approximately 8:30 a.m. (CDT) ... discussing the company,s 2017 financial performance and guidance for ... opportunities, initiatives to enhance operational performance, and long-range financial ...
Breaking Medicine Technology: