Navigation Links
Takeda Announces PDUFA Action Date for Investigational Type 2 Diabetes Therapies Alogliptin and the Fixed-Dose Combination Alogliptin/Pioglitazone
Date:11/1/2011

DEERFIELD, Ill., Nov. 1, 2011 /PRNewswire/ -- Takeda Global Research & Development Center, Inc., (Takeda) announced that the U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) action date of January 25, 2012 for the review of its investigational type 2 diabetes therapy alogliptin, and the fixed-dose combination therapy alogliptin/pioglitazone, which combines alogliptin with pioglitazone in a single tablet.  

Currently, the FDA is reviewing the new drug applications (NDA) for the investigational therapies, which were resubmitted on July 25, 2011; the FDA has categorized these as Class 2 responses, requiring up to six months for review. Alogliptin is a selective dipeptidyl peptidase IV inhibitor (DPP-4i) under investigation in the United States (U.S.) for the treatment of type 2 diabetes as an adjunct to diet and exercise. Discovered by Takeda San Diego, Inc., alogliptin is designed to slow the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide), which play a role in regulating blood glucose levels. Pioglitazone was approved in 1999 for the treatment of type 2 diabetes as an adjunct to diet and exercise. If approved, alogliptin/pioglitazone will be the first type 2 diabetes treatment option in the U.S. to include both a DPP-4 inhibitor and a thiazolidinedione (TZD) in a single tablet.

According to the International Diabetes Federation, a staggering 285 million individuals were living with diabetes worldwide in 2010.

"As recent figures indicate that diabetes continues to be a serious global health challenge, Takeda remains deeply committed to researching new and important therapeutic options for patients living with type 2 diabetes," said David Recker, M.D., senior vice president, clinical science, Takeda Global Research & Development Center. "Phase 3 studies have demonstrated that the combination of a
'/>"/>

SOURCE Takeda Global Research & Development Center, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Takeda Initiates Phase 3 Clinical Trial Program in the United States, Latin America, and Europe for Investigational Type 2 Diabetes Therapy TAK-875
2. Takeda Completes Acquisition and Names New CEO of Nycomed
3. Amylin and Takeda Discontinue Development of Pramlintide/Metreleptin Combination Treatment for Obesity Following Commercial Reassessment of the Program
4. Takeda Resubmits New Drug Applications in the U.S. for Investigational Type 2 Diabetes Therapies Alogliptin and the Fixed-Dose Combination Alogliptin/Pioglitazone
5. Takeda Responds to U.S. Food and Drug Administration Update to Safety Review of ACTOS (pioglitazone HCl)
6. Takeda to Acquire Nycomed
7. Amylin and Takeda Voluntarily Suspend Clinical Activities in Obesity Trial
8. Intra-Cellular Therapies and Takeda Enter into Worldwide Collaboration to Develop and Commercialize Compounds for Schizophrenia
9. Handa Pharmaceuticals Announces Submission of Its First-to-File ANDA for Takedas DEXILANT®
10. Takeda Submits New Drug Application in the U.S. for Azilsartan Medoxomil Plus Chlorthalidone, an Investigational Fixed-Dose Combination for the Treatment of Hypertension
11. Takeda Enters Into Global Strategic Partnerships With Covance and Quintiles
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/23/2015)... BIRMINGHAM, Ala. , Jan. 23, 2015 Gem ... (STS) patients have been enrolled into the Company,s Phase ... efficacy and safety of Gem,s lead compound, GPX-150 (an ... for advanced or metastatic disease. Logo - ...
(Date:1/22/2015)... BOULDER, Colo. , Jan. 22, 2015  BiOptix is ... Klakamp as Vice President of Chemistry and Biochemistry. Scott ... Takeda Pharmaceuticals, AstraZeneca Pharmaceuticals, and Amgen throughout the course ... and development. "Scott is a nationally recognized ...
(Date:1/22/2015)... AMGN ) today announced that it will report its ... 27, 2015, after the close of the U.S. financial markets. The ... community at 2 p.m. PT. Participating in the call from Amgen ... officer, and other members of Amgen,s senior management team. ...
Breaking Medicine Technology:Gem Pharmaceuticals Announces Enrollment of Initial Patients in its Phase 2 Clinical Trial to Assess the Efficacy and Safety of GPX-150 in Sarcoma Patients 2BiOptix Expands Leadership Team with the Appointment of Dr. Scott Klakamp as Vice President of Chemistry and Biochemistry 2Amgen Announces Webcast of 2014 Fourth Quarter and Full Year Financial Results 2
... Jan. 14, 2011   The Cleveland Clinic and Valence ... the Clinic,s effort to become a clinically integrated network. ... the Cleveland Clinic Hospitals, physicians, and more than 1,000 ... Clinic, through its Community Physician Partnership (CPP), recognized the ...
... 2011 New Product Planning (NPP) groups play a vital ... set the stage for a successful launch. One of the ... activities such as ad boards, and thought leader identification and ... New Product Planning: Role and Activities for Medical Affairs ...
Cached Medicine Technology:Valence Health Selected by Cleveland Clinic to Support Clinical Integration Program 2Best Practices, LLC Research Highlights Critical Role of Medical Affairs in New Product Launch Success 2
(Date:1/22/2015)... New York, NY (PRWEB) January 22, 2015 ... American College of Sports Medicine flagship journal Medicine ... supplementation with L-Citrulline before exercise may help reduce ... strenuous exercise. 1 , Participants in the ...
(Date:1/22/2015)... 2015 Recently, Weddingshe.com has added many trendy ... announced its highest annual revenues in the past three years. ... glamorous wedding dresses. , According to the sales manager of ... promotions for them in 2015. This point can be reflected ...
(Date:1/22/2015)... 22, 2015 Four years since the release of ... coincided with the marriage of Avasa & Matthew Love – the ... is scheduled for release through White Swan Records on February 24, ... is a sacred path available to all of us to walk ...
(Date:1/22/2015)... EBSCO Information Services (EBSCO) and the ... an effort to further promote visibility and adoption of the ... made AMA journals available via its subscription services, EBSCO will ... , Long known as both a subscription agency ...
(Date:1/22/2015)... January 22, 2015 JJsHouse.com is a famous ... Today, the business announces its latest collection of wedding ... “The most important issue is the wedding dress on your ... in a woman’s life. Every bride wants to find the ...
Breaking Medicine News(10 mins):Health News:Study Shows Kyowa Hakko’s L-Citrulline May Help Reduce Gastrointestinal Injury During Strenuous Exercise 2Health News:Study Shows Kyowa Hakko’s L-Citrulline May Help Reduce Gastrointestinal Injury During Strenuous Exercise 3Health News:Weddingshe Announces A Special Offer On Its Popular Glamorous Wedding Dresses 2Health News:THE ROAD by Avasa & Matthew Love -- A New Album 2Health News:THE ROAD by Avasa & Matthew Love -- A New Album 3Health News:THE ROAD by Avasa & Matthew Love -- A New Album 4Health News:EBSCO Expands Partnership with the American Medical Association 2Health News:EBSCO Expands Partnership with the American Medical Association 3Health News:EBSCO Expands Partnership with the American Medical Association 4Health News:Find The Most Suitable Wedding Dress At JJsHouse.com 2
... administration, planning to make the city 'smoke-free' from July, Wednesday ... a meeting of the committee set up to work out ... was decided to empower police officials of the rank of ... by recovering the penalty from the offender on the spot. ...
... confessed to aborting over 250 female fetuses, adding he has lost ... his nursing home over the last decade. ,A.K. Singh ... in Pataudi town near here and discovered the dumped fetuses from ... has confessed that he has aborted more than 250 unborn female ...
... IT business unit of India's Wipro Ltd with presence ... an eco-friendly range of desktops and laptops that ... ,The new range of products, christened Wipro GreenWare, is ... ,The $3-billion IT bellwether has set up an ...
... plight of a one-year-old child whose leg had been ... High Court has asked the government and hospital authorities ... to his parents for his upbringing. ,Taking suo ... of Justices T.S. Thakur and S.N. Aggarwal earlier this ...
... reason behind her dramatic weight loss over the past few months, ... reason. ,Jolie told reporters at the New York ... shes lost weight is because shes not only still grieving over ... cancer in January, but also busy running around four young kids. ...
... new study by University of Illinois researchers describes how ... pathology of type 2 diabetes . ,Published ... a number of cytokines, protein signals that bind to ... of biochemical reactions within the cell. ,Interleukins, ...
Cached Medicine News:Health News:Quack of Gurgaon Confesses of Aborting 250 Female Fetuses 2Health News:Child Seeks Compensation for Medical Negligence 2Health News:Cytokine Resistance Contributes to Pathology of Type 2 Diabetes 2
Conducting disposable tips provide cross-contaminationfree pipetting for sensitive applications such as PCR setup....
... to optimize the accuracy and precision of ... is widely recognized by customers throughout the ... over the years and now covers a ... including filter tips, certified pure tips, stepper ...
... the Finntip Wide is designed especially for ... genomic DNA. This tip eliminates the mechanical ... excellent for use with extremely viscous liquids. ... of the orifice is 1.1 mm or ...
Capillary section fits into a 0.3-mm well for accurate loading of sequencing gels...
Medicine Products: