Navigation Links
Takeda Submits New Drug Application in the U.S. for Investigational Type 2 Diabetes Therapy, Fixed-Dose Combination Alogliptin/Metformin
Date:11/23/2011

OSAKA, Japan and DEERFIELD, Ill., Nov. 23, 2011 /PRNewswire/ -- Takeda Pharmaceutical Company Limited (Takeda) announced today that its wholly-owned subsidiary Takeda Global Research & Development Center, Inc., U.S., submitted a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for the fixed-dose combination therapy alogliptin/metformin, which combines alogliptin with metformin in a single tablet. The FDA is expected to review the NDA submission within the next ten months, the standard review period for a new application.

"This NDA submission further extends Takeda's commitment to offering patients with type 2 diabetes a range of therapeutic options to help them manage their condition," noted Thomas Strack, M.D., vice president, clinical science, Takeda Global Research & Development Center, Inc., U.S. "The worldwide incidence of type 2 diabetes continues to expand at a rapid rate and we continue our research into additional medications to treat these patients."

Alogliptin is a 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. Metformin is a widely used diabetes medication that acts primarily by reducing the amount of glucose produced by the liver. These medications work in combination to help patients with type 2 diabetes manage their blood glucose levels.  

Common adverse reactions reported in greater than or equal to 5 percent of patients treated with co-administration of alogliptin with metformin were: upper respiratory tract infection, nasopharyngitis, creatinine renal clearance decreased, diarrhea, headache, hypertension, and urinary tract infection.

About Type 2 Diabetes

Type 2 diabetes is the most common form of diabetes and has reached epidemic proportions globally. More than 23 million Americans currently live with type 2 diabetes, and at least seven million are unaware that they have it. Type 2 diabetes is a progressive and chronic condition, and patients should work with a health care professional to manage and monitor their disease. In addition to diet and exercise, patients often need to take medication in order to help manage glucose control. The global health care expenditures to treat diabetes and prevent its complications were estimated at $376 billion in 2010. By 2030, this number is projected to exceed $490 billion.

About Alogliptin and Alogliptin/Pioglitazone

Alogliptin is a DPP-4i being investigated, as an adjunct to diet and exercise, for the treatment of type 2 diabetes. DPP-4 inhibitors address insulin deficiency by slowing the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide). As a result, an increased amount of active incretins enables the pancreas to secrete insulin in a glucose-dependent manner, thereby assisting in the management of blood glucose levels. An NDA for alogliptin was approved in April 2010 by the Japanese Ministry of Health, Labour and Welfare for the treatment of type 2 diabetes, and the therapy is currently available under the brand name NESINA in this market.

Alogliptin/pioglitazone is a fixed-dose combination therapy in development for the treatment of type 2 diabetes, which combines alogliptin and pioglitazone in a single tablet. Pioglitazone is a thiazolidinedione that directly targets insulin resistance, a condition in which the body does not efficiently use the insulin it produces to control blood glucose levels. It is approved in adults for the treatment of type 2 diabetes as an adjunct to diet and exercise. An NDA for the alogliptin/pioglitazone fixed-dose combination was approved in July 2011 by the Japanese Ministry of Health, Labour and Welfare for the treatment of type 2 diabetes, and the therapy is currently available under the brand name LIOVEL in this market.

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 and cardiovascular treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for metabolic and cardiovascular disease, gastroenterology, neurology and other conditions. To learn more about these Takeda companies, visit www.tpna.com.

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 strive towards better health for patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.


'/>"/>
SOURCE Takeda Pharmaceutical Company Limited
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. U.S. Food and Drug Administration (FDA) Delays Review of Takedas Investigational Type 2 Diabetes Therapies, Alogliptin and Alogliptin/Pioglitazone
2. Takeda Announces PDUFA Action Date for Investigational Type 2 Diabetes Therapies Alogliptin and the Fixed-Dose Combination Alogliptin/Pioglitazone
3. Takeda Initiates Phase 3 Clinical Trial Program in the United States, Latin America, and Europe for Investigational Type 2 Diabetes Therapy TAK-875
4. Takeda Completes Acquisition and Names New CEO of Nycomed
5. Amylin and Takeda Discontinue Development of Pramlintide/Metreleptin Combination Treatment for Obesity Following Commercial Reassessment of the Program
6. Takeda Resubmits New Drug Applications in the U.S. for Investigational Type 2 Diabetes Therapies Alogliptin and the Fixed-Dose Combination Alogliptin/Pioglitazone
7. Takeda Responds to U.S. Food and Drug Administration Update to Safety Review of ACTOS (pioglitazone HCl)
8. Takeda to Acquire Nycomed
9. Amylin and Takeda Voluntarily Suspend Clinical Activities in Obesity Trial
10. Intra-Cellular Therapies and Takeda Enter into Worldwide Collaboration to Develop and Commercialize Compounds for Schizophrenia
11. Handa Pharmaceuticals Announces Submission of Its First-to-File ANDA for Takedas DEXILANT®
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/23/2017)... March 23, 2017 The key factors ... increasing diabetic population, accelerating economic growth and increasing healthcare expenditure. ... are higher life expectancy of ESRD patients, rising demand for ... However, the expansion of the market is hindered by high ... ...
(Date:3/23/2017)... , March 23, 2017 As a ... along with the prevalence of allergic diseases, cutting ... are currently revolutionising the ways in which pharmaceutical ... Allergies 2017 promises to be both a high ... the allergy interest groups, immunologists, research scholars and ...
(Date:3/23/2017)... AUSTIN, Texas , March 23, 2017 /PRNewswire/ ... www.digitalpharmacist.com ), a rapidly growing digital ... PocketRx, a mobile app that allows patients to ... including multi-store locations such as Denver Health Pharmacy, ... app. The acquisition helps Digital Pharmacist accelerate its ...
Breaking Medicine Technology:
(Date:3/23/2017)... Braunfels, TX (PRWEB) , ... March 23, 2017 , ... ... new clinic, located at 960 Gruene Road in Building 2. The clinic is the ... Dr. Andrew Bennett, PT, says opening the company’s second New Braunfels location brings things ...
(Date:3/23/2017)... PA and Grimsby, Ontario (PRWEB) , ... March 23, 2017 , ... The MBI “Hall ... modular industry or whose acts have had a significant impact on the careers of all ... and Marketing with NRB Inc. was inducted into the MBI’s Hall of Fame. The ...
(Date:3/23/2017)... Austin, TX (PRWEB) , ... March 23, 2017 , ... ... fist-sized organs that pack a punch when it comes to maintaining good health. Every ... every 30 minutes, your kidneys filter every drop of your blood, eliminating waste, regulating ...
(Date:3/23/2017)... Angeles, CA (PRWEB) , ... March 23, 2017 ... ... A funding investment in Los Angeles based healthcare technology company California Healthcom Group ... portfolio into the US, and healthcare arena. With headquarters in California, CHG is ...
(Date:3/23/2017)... ... March 23, 2017 , ... Michael Lanteri ... the greater Fort Collins area, has unveiled a collaboration with nonprofit Big Bones ... Donations to this worthy cause may now be made at http://bigbonescaninerescue.com/ . ...
Breaking Medicine News(10 mins):