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Takeda Responds to the FDA Advisory Committee Recommendation
London (ots/PRNewswire) -
Following a joint meeting today of the U.S. Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, Takeda Global Research & Development (TGRD) underscores its position that ACTOS(R) (pioglitazone HCl) offers a proven safety profile regarding the risk of cardiovascular disease.
"The breadth and depth of ACTOS data - encompassing more than 16,000 patients over the past 10 years-is consistent: Short- and long-term studies have shown no evidence that ACTOS is associated with an increased risk of heart attack or stroke," said Dr. Nico Bruyniks, Director Medical and Scientific Affairs at Takeda Pharmaceuticals Europe LTD. "Critical in this body of data is the PROactive (PROspective PioglitAzone Clinical Trial In MacroVascular Events) study, since the only scientific way to determine a medication's safety is a prospective, long-term trial."
About the PROactive Study
PROactive was a prospective, randomized, placebo-controlled outcomes trial. The PROactive study included 5,238 patients with type 2 diabetes and a history of macrovascular disease, who were force titrated up to 45 mg daily of either ACTOS or placebo. In this study, there was no difference in the number of macrovascular events between standard of care and ACTOS, and standard of care alone. Although the study failed regarding its primary endpoint, which was a composite of all-cause mortality, non-fatal myocardial infarction, stroke, acute coronary syndrome, major leg amputation, coronary revascularisation and leg revascularisation, the results suggest that there are no long-term cardiovascular concerns regarding use of pioglitazone
The ACTOS Summary of Product Characteristics was recently revised by the EMEA to include this reassuring cardiovascular safety data. ACTOS is the only thiazolidinedione (TZD) with safety data from a cardiovascular outcomes trial in its label.
"Although drugs may be in the same class, they also can have different clinical effects due to differences in molecular structure, said Dr. Bruyniks. "ACTOS is an effective and appropriate treatment option for people with type 2 diabetes. Since the introduction of ACTOS in August 1999, almost 70 million prescriptions have been written, covering more than 8 million patients and 4.5 million patient years."
Takeda has consistently emphasized the importance of physician education and patient safety in all communications involving ACTOS and has prioritized communicating the appropriate use of ACTOS in patients with type 2 diabetes.
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 agency is not bound to follow the recommendations. This joint committee meeting reviewed the cardiovascular ischemic/thrombotic risks of the thiazolidinediones, with focus on rosiglitazone, as presented by FDA and GlaxoSmithKline.
ACTOS received its first regulatory approval in July 1999 in the United States. ACTOS was originally approved by the European Medicines Agency for the treatment of type-2 diabetes in October 2000, the original label was most recently extended in January 2007. In Europe, ACTOS is indicated in the treatment of type 2 diabetes mellitus:
@@start.t1@@ as monotherapy
-- in patients (particularly overweight patients) inadequately controlled
by diet and exercise for whom metformin is inappropriate because of
contraindications or intolerance
as dual oral therapy in combination with
-- metformin, in patients (particularly overweight patients) with
insufficient glycaemic control despite maximal tolerated dose of
monotherapy with metformin
-- 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
as triple oral therapy in combination with
-- metformin and a sulphonylurea, in patients (particularly overweight
patients) with insufficient glycaemic control despite dual oral
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
COMPETACT was first launched in Europe in October 2006.
Competact 15mg/850mg tablets containing 15mg pioglitazone as hydrochloride and 850mg of metformin hydrochloride. Indication: Treatment of type 2 diabetes mellitus patients, particularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone.
About Takeda in Europe
Takeda Pharmaceuticals Europe Ltd, based in London, UK, supervises the overall business activities of Takeda's subsidiaries in Europe through promoting pan-European strategies.
Takeda Global Research & Development Center, Inc., based in Deerfield, Ill., USA, and London, U.K., is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited and is responsible for Takeda's clinical research and development in the U.S. and Europe.
Takeda Pharmaceutical Company Limited, located in Osaka, Japan, 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
ACTOS(R) (pioglitazone HCl) is a registered trademark of Takeda Pharmaceutical Company Limited.
ots Originaltext: Takeda Pharmaceuticals Europe Ltd
Im Internet recherchierbar: http://www.presseportal.ch
Jocelyn M. Gerst of Takeda Global Research & Development,
+1-224-554-5542, or Alexander Watson, Ketchum, +44-(0)-20-7611-3663 &