Takeda Responds to FDA Advisory Committee Recommendation
By Takeda Pharmaceuticals Europe Ltd, PRNETuesday, July 13, 2010
LONDON, July 15, 2010 - 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 therapy
Pioglitazone 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 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.
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
Tags: July 15, London, Takeda Pharmaceuticals Europe Ltd, United Kingdom