DEERFIELD, Illinois, September 23, 2010 /PRNewswire/ -- Following today's announcements by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for rosiglitazone in the U.S. and Europe, Takeda Pharmaceuticals North America, Inc. and Takeda Pharmaceuticals Europe Limited ("Takeda") underscore the company's commitment to pioglitazone (an active ingredient in Actos(R), Competact(R), Glustin(R), Glubrava(R), and Tandemact(R)) and to the millions of people living with type 2 diabetes.
As this news may cause concern or confusion among people with type 2 diabetes, Takeda encourages those with questions to speak with their health care provider. Takeda has consistently emphasized the importance of physician education and patient safety in communications involving pioglitazone, and has prioritized communicating the appropriate use of pioglitazone in patients with type 2 diabetes.
Pioglitazone is an effective prescription medication used with diet and exercise to improve blood sugar (glucose) control in many adults with type 2 diabetes. Since its launch, more than 100 million pioglitazone prescriptions have been written globally. Pioglitazone offers an established safety profile regarding the risk of cardiovascular (CV) events in people living with type 2 diabetes. Although drugs may be in the same class and have the same use, they also may have different effects due to their unique chemical structure.
Takeda remains confident in the breadth, depth and consistency of pioglitazone data. Controlled clinical studies, conducted over the past 11 years in more than 20,000 patients globally, show no evidence that pioglitazone is associated with an increased risk of heart attack, stroke or death.
In 2005, Takeda was the first company to complete a rigorous, randomized, placebo-controlled study, the PROactive (PROspective PioglitAzone Clinical Trial In MacroVascular Events) trial, assessing significant CV outcomes in people living with type 2 diabetes. The PROactive trial demonstrated that although there was no statistically significant difference between pioglitazone and standard-of-care alone for the primary endpoint, there was no increase in mortality or total macrovascular events with pioglitazone.
This safety information has been included in both the FDA-approved product label and EMA-approved Summary of Product Characteristics (SPC) since 2007, providing patients and health care professionals with additional relevant information regarding the CV safety profile of pioglitazone.
Takeda is the inventor and developer of pioglitazone, which was launched commercially in 1999. Pioglitazone, as labelled, is an effective and appropriate treatment option for many people living with type 2 diabetes. Certain patients with heart failure should not start taking pioglitazone. Pioglitazone can cause new or worsen heart failure.
About Pioglitazone Indications and Usage
Pioglitazone is a prescription medication used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. Within the European Union pioglitazone** is approved for use for type 2 diabetes as monotherapy in patients who cannot tolerate metformin; in combination with metformin for patients who are not satisfactorily controlled on metformin alone; in combination with a sulphonylurea in patients for whom metformin is not suitable and who are not satisfactorily controlled with a sulphonylurea alone; or as triple therapy with metformin and a sulphonylurea in patients who are not satisfactorily controlled by these two medicines alone. Pioglitazone can also be used in combination with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.
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 treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for diabetes, cardiovascular disease, gastroenterology, neurology and other conditions. To learn more about these Takeda companies, visit http://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, http://www.takeda.com.
About Takeda Pharmaceuticals Europe Limited (TPEU)
Based in London, Takeda Pharmaceuticals Europe leads the overall business activities of Takeda's European subsidiaries ("TES"), providing strategic direction and management support across the region.
Contacts: Elissa J. Johnsen, Takeda Pharmaceuticals North America, Inc., (Office) +1-224-554-3185, (Cell) +1-312-285-3203; Seizo Masuda, Takeda Pharmaceutical Company, Ltd., (Office) +81-3-3278-2082; Rob Gallo, Takeda Pharmaceuticals Europe Ltd, (Office) +44-203-116-8874, (Cell) +44-7500-012866; Danny Stepto, Red Door Communications, (Office) +44(0)20-8392-8042, (Mobile) +44(0)7957-915691; Phil Sheldon, Red Door Communications, (Office) +44(0)20-8392-8040
