Takeda Pharmaceutical Company Limited
Takeda Responds to FDA Advisory Committee Recommendation
London, July 15, 2010 (ots/PRNewswire)
The U.S. Food and Drug
Administration (FDA) Endocrinologic and Metabolic Drugs Advisory
Committee and the Drug Safety and Risk Management Advisory Committee
held a joint meeting primarily focused on reviewing the
cardiovascular (CV) safety of rosiglitazone, as presented by the FDA
and GlaxoSmithKline. Following this two day discussion, Takeda
Pharmaceuticals North America, Inc. ("Takeda") underscores its
position that ACTOS(R) (pioglitazone HCl) offers an established
safety profile regarding the risk of CV events in people living with
type 2 diabetes.Although drugs may be in the same class and have the same indication, they also may have different effects in other areas due to their specific structure. Takeda remains confident in the breadth, depth and consistency of pioglitazone data.
Pioglitazone studies, conducted over the past 11 years in more than 20,000 patients, show no evidence that pioglitazone was associated with an increased risk of heart attack, stroke or death. Takeda was the first company to complete a rigorous post-marketing study, the PROactive (PROspective PioglitAzone Clinical Trial In MacroVascular Events) trial, assessing critical 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 (placebo) for the primary endpoint, there was no increase in mortality or total macrovascular events with pioglitazone. This safety information is reflected in the approved product label since 2007, providing patients and health care professionals with additional relevant information regarding the CV safety profile of pioglitazone.
Advisory Committee meetings are discussions of pending applications and other public health matters. The FDA frequently convenes its panel of outside experts to provide guidance and recommendations; however, the recommendations of the committee are not a final decision. The FDA will evaluate the committee's decision and their final recommendations will follow.
Takeda remains committed to pioglitazone and to the millions of people living with type 2 diabetes. Takeda is the inventor and developer of pioglitazone, which was launched commercially in Europe and the U.S. in 1999. Pioglitazone, as labeled, is an effective and appropriate treatment option for many people living with type 2 diabetes. Since its launch, more than 100 million pioglitazone prescriptions have been written, covering more than 10 million patients. In clinical trials using pioglitazone in monotherapy, pioglitazone is generally well tolerated. The most common adverse events (1-10%) were visual disturbance, upper respiratory tract infection, weight increase, and hypoaesthesia.
Notes to Editors
About pioglitazone
In Europe, pioglitazone is indicated in the treatment of type 2 diabetes mellitus:
- Monotherapy in patients (particularly overweight patients)
inadequately controlled by diet and exercise for whom metformin is
inappropriate because of contraindications or intolerance
- Dual oral therapy in combination with metformin, in patients
(particularly overweight patients) with insufficient glycaemic
control despite maximal tolerated dose of monotherapy with metformin
or in combination with a sulphonylurea, only in patients who show
intolerance to metformin or for whom metformin is contraindicated,
with insufficient glycaemic control despite maximal tolerated dose of
monotherapy with a sulphonylurea
- Triple oral therapy in combination with metformin and a
sulphonylurea, in patients (particularly overweight patients) with
insufficient glycaemic control despite dual oral therapyPioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance.
Pioglitazone is ACTOS and an active ingredient in Competact, Glustin, Glubrava and Tandemact.
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 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.Contact:
CONTACT: Media Contacts: Nick Francis, Takeda Pharmaceuticals Europe
Ltd,(Office) +44(0)20-3116-8861, (Mobile) +44(0)7500-012-866 ; Danny
Stepto,Red Door Communications, Office) +44(0)20-8392-8042,
(Mobile)+44(0)7957-915-691 ; Con Franklin, Red Door Communications,
(Office) +44(0)20 8392 8061, (Mobile) +44(0)7889-723-721