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 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 ACTOS and to the millions of people living with type 2 diabetes. Takeda is the inventor and developer of ACTOS, which was launched commercially in the U.S. in 1999. ACTOS, as labeled, is an effective and appropriate treatment option for many people living with type 2 diabetes. Since its launch, more than 100 million ACTOS family prescriptions have been written, covering more than 10 million patients. In clinical trials using ACTOS in monotherapy, the most common adverse events (greater than or equal to 5%) were upper respiratory tract infection, headache, sinusitis, myalgia, tooth disorder, aggravated diabetes mellitus, and pharyngitis.
Takeda Pharmaceuticals North America, Inc.