Navigation Links
U.S. Food and Drug Administration (FDA) Delays Review of Takeda's Investigational Type 2 Diabetes Therapies, Alogliptin and Alogliptin/Pioglitazone
Date:11/18/2011

DEERFIELD, Ill., and OSAKA, Japan, Nov. 18, 2011 /PRNewswire/ -- Takeda Pharmaceutical Company Limited (Takeda) and its wholly-owned subsidiary, Takeda Global Research & Development Center, Inc., U.S., today announced that the company received notification from the U.S. Food and Drug Administration (FDA) that its review of investigational type 2 diabetes therapy alogliptin, and thus the fixed-dose combination therapy alogliptin/pioglitazone, will be delayed. The new Prescription Drug User Fee Act (PDUFA) action date has been set for April 25, 2012. The FDA originally assigned a PDUFA action date of January 25, 2012.

"Takeda is confident in alogliptin and alogliptin/pioglitazone as potential therapeutic options for the millions of patients living with type 2 diabetes," said David Recker, M.D., senior vice president, clinical science, Takeda Global Research & Development Center, Inc., U.S. "We will work closely with the FDA to determine the appropriate next steps, and are dedicated to continuing our efforts to bring these important therapies to market in the U.S."

Alogliptin is a highly potent and highly selective dipeptidyl peptidase IV inhibitor (DPP-4i) under investigation in the 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 roles in regulating blood glucose levels. Alogliptin/pioglitazone combines alogliptin with pioglitazone, two complementary agents with distinct mechanisms of action, and if approved, 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. Pioglitazone was approved in 1999 for the treatment of type 2 diabetes as an adjunct to diet and exercise.

There is no change in Takeda's fiscal 2011 financ
'/>"/>

SOURCE Takeda Pharmaceutical Company Limited
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Biological Psychiatry Publishes Study Showing VYVANSE Demonstrated Significant Efficacy for Treatment of ADHD for up to 12 Hours After Administration
2. Supplemental New Drug Application for PREZISTA(TM) Submitted to U.S. Food and Drug Administration
3. Northwestern Offers Clinical Research and Regulatory Administration Graduate Certificate Program
4. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
5. Ortho Biotech Statement on U.S. Food and Drug Administration Oncologic Drugs Advisory Committee Vote
6. U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
7. Treprostinil Data Presented at American Thoracic Society Conference Demonstrates Significant Clinical Progress in All Four Routes of Administration
8. Lilly Submits Cymbalta(R) Supplemental New Drug Application for Chronic Pain to U.S. Food and Drug Administration
9. Genmab A/S - Company Announcement Ofatumumab in Subcutaneous Study in Rheumatoid Arthritis Summary: Subcutaneous Administration of Ofatumumab Investigated in Phase I/II Study
10. Vermillion Files 510(k) Application With U.S. Food & Drug Administration for OVA1 Ovarian Tumor Triage Test
11. New Drug Application for Inhaled Treprostinil Submitted to the U.S. Food and Drug Administration
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/1/2014)... 2014 The Cardinal Health 2014 digital ... can learn about the company,s fiscal year ... the health care continuum by accessing the ... Photo- http://photos.prnewswire.com/prnh/20140930/149504-INFO ... chief executive officer,s letter to shareholders, the ...
(Date:10/1/2014)... NEW YORK , October 1, 2014 ... service provider for the medical industries, announced today the expansion of ... New York City . genae Americas was incorporated in ... strategically centered in one of the highest concentrations of medical innovation ... Kassab , President at genae Americas. "The expansion of genae from ...
(Date:10/1/2014)...  Express Scripts (NASDAQ: ESRX ) today ... Medicare ® Prescription Drug Plans (PDP) will offer ... WAG ) (NASDAQ: WAG ), helping ...  for their Medicare dollars. Medicare beneficiaries who ... or Choice plans for 2015 can save ...
Breaking Medicine Technology:Cardinal Health 2014 Digital Report to Shareholders Now Available 2genae Opens Offices in New York City 2Express Scripts Collaborates with Walgreens to Create Value-Driven Medicare Prescription Drug Plan Pharmacy Network 2Express Scripts Collaborates with Walgreens to Create Value-Driven Medicare Prescription Drug Plan Pharmacy Network 3Express Scripts Collaborates with Walgreens to Create Value-Driven Medicare Prescription Drug Plan Pharmacy Network 4
... EAST RUTHERFORD, N.J., Nov. 1, 2011 Cambrex Corporation ... 2011 financial results will be released on Thursday, November ... The Company will host a conference call to discuss ... Conference CallWhen: , Friday, November 4, 2011 at 8:30 ...
... 2011 Takeda Global Research & Development ... Drug Administration (FDA) has assigned a Prescription Drug User ... for the review of its investigational type 2 diabetes ... combines alogliptin with pioglitazone in a single tablet.   ...
Cached Medicine Technology:Takeda Announces PDUFA Action Date for Investigational Type 2 Diabetes Therapies Alogliptin and the Fixed-Dose Combination Alogliptin/Pioglitazone 2Takeda Announces PDUFA Action Date for Investigational Type 2 Diabetes Therapies Alogliptin and the Fixed-Dose Combination Alogliptin/Pioglitazone 3
(Date:10/1/2014)... scientists has shown that more than 80 per cent ... , The study found that medicines called ,JAK inhibitors, ... mutation that is present in more than 80 per ... used, or are in clinical trials, for diseases including ... Bowel cancer is the second-most common cancer in Australia ...
(Date:10/1/2014)... of the human eye, the brain of a rat ... new technology, says a QUT leading robotics researcher. ... Faculty says the new study uses new computer algorithms ... buildings or tunnels. , "This is a very Frankenstein ... two halves of a thing together because we,re taking ...
(Date:10/1/2014)... Philadelphia, PA, October 1, 2014 Patients with ... treatment, have a greatly increased risk of depression. ... therapy for chronic hepatitis C virus infection causes ... Omega-3 fatty acids, more commonly known as fish ... including lowering the risk of heart disease and ...
(Date:10/1/2014)... New research suggests the adage that encourages people to ... target when it comes to exercise. When walking, staying ... distance to it appear shorter and help people walk ... compares this technique to walking while looking around the ... quality of exercise. , "People are less interested in ...
(Date:10/1/2014)... 2014 Marriagelifeinsurance.com has released a ... for retired couples. , Senior citizens can purchase ... for their loved ones. A joint policy is cheaper, ... pass away. , Life insurance can be used ... can even be purchased online, as the application process ...
Breaking Medicine News(10 mins):Health News:Eighty percent of bowel cancers halted with existing medicines 2Health News:Robot researcher combines nature to nurture 'superhuman' navigation 2Health News:Omega-3 fatty acids may prevent some forms of depression 2Health News:Keeping your eyes on the prize can help with exercise, NYU study finds 2Health News:Keeping your eyes on the prize can help with exercise, NYU study finds 3Health News:Elderly Life Insurance - Find Life Insurance for Retired Couples! 2
... , , AUSTIN, Texas, ... processing expert, ThermoGenesis Corp., to deliver the most sophisticated point ... innovative MarrowXpress(TM) (MXP(TM)) System defines a new standard for isolation ... MXP System consistently yields high (> 90%) mononuclear cell recovery ...
... Global health organization PSI helps contestants spread HIV prevention messages throughout ... 21 The Miss Universe contestants continued preparations for Sunday night,s ... condoms to test their strength and playing "Wild Fire Infection" games ... are part of an HIV peer education workshop designed by PSI ...
... , , KUALA LUMPUR, ... Technologies (ICT) is essential for modern healthcare delivery systems if ... and improve patient safety. , , (Logo: ... years, the acquisition of computer technologies by healthcare organizations has ...
... treatment to thousands who need it, experts say ... with patient and therapist texting each other in real-time ... of patients new access to much-needed treatment, researchers say. ... of research and practice involving technology-based treatments for depression ...
... , , , ... (Nasdaq: HTWR - ASX: HIN) today announced that HeartWare has surpassed ... marking an important early enrollment milestone. , , ... at the Texas Heart Institute in Houston, Texas by O.H. Frazier, ...
... N.Y. The Bioproduction Facility at Cornell University has ... vaccinethat will be used in clinical trials for patients ... was developed as a partnership between The Ludwig Institute ... trial is being conducted at New York University Medical ...
Cached Medicine News:Health News:Celling Technologies Sets New Standards With Sophisticated Adult Stem Cell Device 2Health News:Celling Technologies Sets New Standards With Sophisticated Adult Stem Cell Device 3Health News:Miss Universe Contestants Enter Condom Olympics to Tackle HIV 2Health News:Miss Universe Contestants Enter Condom Olympics to Tackle HIV 3Health News:Frost & Sullivan: Medico Legal Implications Related to the Usage of Electronic Health Record 2Health News:Frost & Sullivan: Medico Legal Implications Related to the Usage of Electronic Health Record 3Health News:Frost & Sullivan: Medico Legal Implications Related to the Usage of Electronic Health Record 4Health News:Web-Based Psychotherapy Can Work 2Health News:Web-Based Psychotherapy Can Work 3Health News:HeartWare International Surpasses 50 Implants in the US 2Health News:HeartWare International Surpasses 50 Implants in the US 3Health News:Cornell makes cancer vaccine for clinical use 2Health News:Cornell makes cancer vaccine for clinical use 3
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
Medicine Products: