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Takeda Responds to FDA Advisory Committee Recommendation
Date:7/14/2010

DEERFIELD, Ill., July 14 /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® (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 ACTOS data.

ACTOS studies, conducted over the past 11 years in more than 20,000 patients, show no evidence that ACTOS 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 ACTOS and standard-of-care (placebo) for the primary endpoint, there was no increase in mortality or total macrovascular events with ACTOS. This safety information has been included in the FDA-approved product label since 2007, providing patients and health care professionals with additional relevant information regarding the CV safety profile of ACTOS.

Advisory Committee meetings are discussions of pending applications a
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SOURCE Takeda Pharmaceuticals North America, Inc.
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