Navigation Links
Takeda submits new drug application for alogliptin (syr-322) in the US
Date:1/4/2008

Deerfield, IL, January 3, 2008 --- Takeda Pharmaceutical Company Limited (Takeda) announced today that Takeda Global Research & Development Center, Inc. submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for alogliptin (development code: SYR-322), a highly selective dipeptidyl peptidase-4 (DPP-4) inhibitor under investigation for the treatment of type 2 diabetes. Discovered by Takeda San Diego, Inc., alogliptin was designed to selectively inhibit DPP-4 taken orally once daily.

DPP-4 inhibitors are a new class of oral agents for the treatment of type 2 diabetes, which slow the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide). The incretins play a major role in regulating blood glucose levels and may have the potential to improve pancreatic beta-cell function.

The NDA submission was supported by six Phase 3 clinical trials involving over 2,000 patients conducted in 220 centers worldwide. The safety and efficacy of alogliptin was studied as a once-daily monotherapy adjunct to diet and exercise and as an add-on therapy to other antidiabetic medications including sulfonylureas, metformin, thiazolidinediones (TZDs), and insulin. In the studies, alogliptin was associated with statistically significant reductions in hemoglobin A1c, which reflects average blood glucose concentration over the previous two to three months. Alogliptin was generally well-tolerated and weight neutral. There was no increase in hypoglycemia compared to placebo.

The NDA submission for alogliptin is a significant milestone for Takeda, as it has the potential to position us as one of the global leaders in diabetes treatment, said Yasuchika Hasegawa, president of Takeda. Takedas continued growth, now and in the future, will be based on our ability to focus and have success in this therapeutic area. Our hope is that alogliptin will become an important treatment option for patients with type 2 diabetes and the healthcare providers who treat them.

GLP-1 and GIP are produced by the digestive tract in response to food, and regulate glucose balance, primarily by stimulating glucose-dependent insulin secretion. In addition, GLP-1 suppresses pancreatic glucagon secretion and subsequent liver glucose production, enhances glucose disposal, slows gastric emptying, and elicits satiety, a feeling of fullness.


'/>"/>

Contact: Carrie Rose
carrie.rose@ketchum.com
646-935-3938
Takeda Pharmaceuticals North America
Source:Eurekalert

Related medicine news :

1. Chemizon Announces Research Collaboration Expansion With Takeda
2. Takeda Statement on ACTOS(R) (Pioglitazone HCl) Meta-Analysis Published in the Journal of the American Medical Association
3. Takeda statement on ACTOS meta-analysis published in the Journal of the American Medical Association
4. XTENT Submits CE Mark Registration to Market Custom NX(R) Drug-Eluting Stent System in Europe
5. ImaRx Therapeutics Submits Urokinase Data to FDA Supporting Extended Expiration Dating
6. Millennium Submits sNDA for VELCADE(R) (Bortezomib) for Injection for the Treatment of Front-Line Multiple Myeloma
7. ISTA Pharmaceuticals Submits New Drug Application for Xibrom(TM) QD (once-daily)
8. SGX Pharmaceuticals Submits Investigational New Drug Application for SGX523, a Highly Potent, Selective, Orally Bioavailable cMET Inhibitor
9. Johnson & Johnson Pharmaceutical Research & Development Submits New Drug Application for Paliperidone Palmitate
10. Global Med Technologies(R), Inc. Submits ElDorado Donor(TM) to FDA
11. Cephalon Submits New Drug Application for TREANDA for the Treatment of Chronic Lymphocytic Leukemia
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/23/2017)... ... February 23, 2017 , ... ... and community for those in the fight against cancer, has produced a seminal ... success. HRA will release top-line findings in a webinar, Defining Compassionate Care ...
(Date:2/23/2017)... ... (PRWEB) February ... for the nation to come together to combine its favorite ... with its favorite fruit – apples! To celebrate National Nutrition ... join the “Apple Madness” bracket tournament – a five-week, five-round ...
(Date:2/23/2017)... , ... February 23, 2017 , ... Top cosmetic and ... Patriot program today with a new Indiegogo campaign . Individuals are now ... veterans in the Los Angeles area, either as a participating patient or through an ...
(Date:2/23/2017)... , ... February 23, 2017 , ... HealthPostures, the desk ... an expert sit stand solutions representative to the Minneapolis Home and Garden Show which ... the event that is garnering national attention is the Minneapolis Convention Center. , ...
(Date:2/23/2017)... ... February 23, 2017 , ... Carlos Gutierrez ... has also continued to spiritually evolve, which is the purpose of everyone in this ... Spiritual Truths ” (published by Balboa Press) attempts to guide readers to expand one’s ...
Breaking Medicine News(10 mins):
(Date:2/23/2017)... 2017 Mixed tocopherols market projected to grow at ... is projected to reach USD 5.27 billion by 2022, at ... by factors such as health and wellness trends, for instance, ... regulations for sourcing, processing, packaging, and labeling of food & ... such as the Asia-Pacific region also ...
(Date:2/22/2017)... a condition where an organ of ... to weak abdominal wall. Hernia is classified into ... femoral hernia, umbilical hernia, and other (hiatal hernia ... are performed using a mesh, made-up of biological ... Among the available options, open tension-free repair procedures ...
(Date:2/22/2017)... , Feb. 22, 2017 Summary ... partnering deals and agreements entered into by the worlds ... http://www.reportlinker.com/p03605680-summary/view-report.html Description The Global Spinal Cord Partnering ... access to partnering deals and agreements entered into by ... in partnering deals - Top deals by value ...
Breaking Medicine Technology: