Navigation Links
Takeda Submits a New Drug Application in the U.S. for Alogliptin (SYR-322) / ACTOS(R) (pioglitazone HCl) for the Treatment of Type 2 Diabetes
Date:9/23/2008

OSAKA, Japan, Sept. 23 /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 U.S. Food and Drug Administration (FDA) for marketing approval of alogliptin (SYR-322) and ACTOS(R) (pioglitazone HCl) ("alogliptin/ACTOS") in a single tablet for the treatment of type 2 diabetes.

Alogliptin was discovered by Takeda's wholly owned subsidiary, Takeda San Diego, Inc., and is a member of the DPP-4 inhibitors class, which are newer oral agents for the treatment of type 2 diabetes. DPP-4 inhibitors slow the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic polypeptide). The incretins play a major role in regulating blood glucose levels and have the potential to improve pancreatic beta-cell function. 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. Takeda is the originator of the thiazolidinedione (TZD) class of oral anti-diabetes medications. ACTOS is a TZD that directly targets insulin resistance, a condition in which the body does not efficiently use the insulin it produces to control blood glucose levels.

"Alogliptin/ACTOS, if approved, will be the first type 2 diabetes treatment option which includes a DPP-4 inhibitor and a TZD," said Yasuchika Hasegawa, President of Takeda. "Given the increased global incidence of type 2 diabetes and the need for new treatment options, we will strive to provide alogliptin/ACTOS, as a potentially important treatment option, to patients and healthcare providers."

The NDA submission was supported by two phase 3 clinical trials, involving more than 2,000 patients worldwide. The studies assessed the efficacy and safety of this therapy for the treatment of patients with type 2 diabetes not achieving glycemic targets with diet and exercise alone, or for patients uncontrolled on metformin. Study results showed that alogliptin/ACTOS produced significant improvements in glycemic control and measures of insulin resistance and beta-cell function. In clinical trials, alogliptin/ACTOS was generally well-tolerated. Side effects included headache, cold-like symptoms and back pain.

Important Safety Information About ACTOS(R) (pioglitazone HCl)

ACTOS works by directly targeting insulin resistance, a condition in which the body does not efficiently use the insulin it produces to control blood glucose levels. ACTOS, a prescription medication, is taken once daily as an adjunct to diet and exercise, and is approved for use for type 2 diabetes as monotherapy to lower blood glucose and in combination therapy with insulin, sulfonylureas or metformin.

ACTOS is not for everyone. Certain patients with heart failure should not start taking ACTOS. ACTOS can cause or worsen congestive heart failure. Talk to your doctor immediately if you experience rapid weight gain, fluid retention, or shortness of breath.

Do not take ACTOS if you have active liver disease. Your doctor should perform a blood test to check for liver problems before you start ACTOS and periodically thereafter. Talk to your doctor immediately if you experience nausea, vomiting, stomach pain, tiredness, loss of appetite, dark urine, or yellowing of the skin. If you are of childbearing age, talk to your doctor before taking ACTOS, as it could increase your chance of becoming pregnant. Some people taking ACTOS may experience flu-like symptoms, mild-to-moderate swelling of legs and ankles, and anemia. Some people, particularly women, are at higher risk of having bone fractures while taking ACTOS. When taking ACTOS with insulin or sulfonylureas, you may be at risk for low blood sugar. Patients with diabetes should have regular eye exams. If you experience vision problems, consult your doctor immediately. Very rarely, some patients have experienced visual changes while taking ACTOS.

Please visit the ACTOS Web site at http://www.actos.com for Complete Prescribing Information.

About 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 striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. Additional information about Takeda is available through its corporate Web site, http://www.takeda.com.

ACTOS is a registered trademark of Takeda Pharmaceutical Company Limited.


'/>"/>
SOURCE Takeda Pharmaceutical Company Limited
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Takeda Doses First Patient in a U.S. Phase 1 Study of Hematide(TM) to Treat Chemotherapy Induced Anemia
2. Takeda Submits New Drug Application for Alogliptin (SYR-322) in the U.S.
3. U.S. Navy Submits Protocol for Field Trauma Trial of Hemopure(R)
4. AstraZeneca Submits an sNDA for SYMBICORT(R) for the Treatment of Asthma in Children as Young as Age Six
5. AdvanDx Submits Yeast Traffic Light PNA FISH(TM) for FDA 510(k) Clearance for Detection of Candida species in Positive Blood Cultures
6. AstraZeneca Submits sNDA for NEXIUM(R) I.V. for Peptic Ulcer Bleed Indication
7. Lilly Submits Cymbalta(R) Supplemental New Drug Application for Chronic Pain to U.S. Food and Drug Administration
8. AstraZeneca Submits sNDA for SEROQUEL XR(TM) for the Treatment of Generalized Anxiety Disorder - a First for the Atypical Antipsychotic Class of Medicines
9. AstraZeneca Submits an sNDA for SYMBICORT(R) for COPD Indication
10. Cardica Reports Positive Top-Line Results and Submits 510(k) for PAS-Port(R) Proximal Anastomosis System in Cardiac Bypass Surgery
11. CSL Behring Submits BLA Requesting Approval of C1-Esterase Inhibitor for the Treatment of Hereditary Angioedema
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/29/2017)... 29, 2017  Bodycad announced today that it ... 510(k) clearance for its Bodycad Unicompartmental Knee System, ... orthopaedic restoration. Bodycad is the first Canadian company ... implant system. Bodycad,s revolutionary Unicompartmental ... of the patient,s unique anatomical features and kinematics. ...
(Date:3/29/2017)... Mar. 29, 2017 Research and Markets has ... 2017-2021" report to their offering. ... The global energy-based aesthetic devices market to ... The report, Global Energy-Based Aesthetic Devices Market 2017-2021, has ... industry experts. The report covers the market landscape and its growth ...
(Date:3/29/2017)... -- Global intravenous (IV) iron and oral iron market is ... a CAGR of 5%. Iron drugs are ... anemia or other iron deficiencies. Oral iron supplements are recommended ... some cases, oral administrations are not capable of maintaining the ... comes into the picture. Global Intravenous (IV) Iron ...
Breaking Medicine Technology:
(Date:3/30/2017)... ... March 30, 2017 , ... This morning, more ... Trump expressing their support for an independent Vaccine Safety Commission. Five of the ... medical journalist, will hold a press conference at 9:00 AM Friday, March ...
(Date:3/29/2017)... ... March 29, 2017 , ... In the United States alone, up to 36% ... other types of metastatic brain tumors(3). Though most meningiomas are benign, metastatic brain tumors ... finding more effective treatment options, the San Diego Gamma Knife Center offers ...
(Date:3/29/2017)... ... March 30, 2017 , ... Grass pollen is the main cause of hay fever in ... The season for grass pollen runs from May to July each year; with the worst ... to do? HayMax™ allergen barrier balms ( http://www.haymax.us ) provide an effective defense against grass ...
(Date:3/29/2017)... (PRWEB) , ... March 30, 2017 , ... Sublime Naturals ... "Spice of Life" or "Wonder Spice", it has been used for thousands of years. ... the East," says Heshelow, author of " Turmeric: How to Use it For Your ...
(Date:3/29/2017)... Baton Rouge, Louisiana (PRWEB) , ... March 29, ... ... trademarked HeartBoost in three Hours at a Walgreens store in Mississippi. AngioGenesis Labs, ... campaign at Walgreens Stores in two southeastern states. Ingredients in HeartBoost, an over ...
Breaking Medicine News(10 mins):