Takeda underscores commitment to ACTOS following FDA and EMA announcements for rosiglitazone

Sep 24 2010

Following today’s announcements by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for rosiglitazone in the U.S. and Europe, Takeda Pharmaceuticals North America, Inc. and Takeda Pharmaceuticals Europe Limited (“Takeda”) underscore the company’s commitment to ACTOS^® (pioglitazone HCl) and ACTOS-containing medications, and to the millions of people living with type 2 diabetes.

As this news may cause concern or confusion among people with type 2 diabetes, Takeda encourages those with questions to speak with their health care provider. Takeda has consistently emphasized the importance of physician education and patient safety in communications involving ACTOS, and has prioritized communicating the appropriate use of ACTOS in patients with type 2 diabetes.

ACTOS is an effective prescription medication used with diet and exercise to improve blood sugar (glucose) control in many adults with type 2 diabetes. Since its launch, more than 100 million ACTOS prescriptions have been written globally. ACTOS offers an established safety profile regarding the risk of cardiovascular (CV) events in people living with type 2 diabetes. Although drugs may be in the same class and have the same use, they also may have different effects due to their unique chemical structure.

Takeda remains confident in the breadth, depth and consistency of ACTOS data. Controlled clinical studies, conducted over the past 11 years in more than 20,000 patients globally, show no evidence that ACTOS is associated with an increased risk of heart attack, stroke or death.

In 2005, Takeda was the first company to complete a rigorous, randomized, placebo-controlled study, the PROactive (PROspective PioglitAzone Clinical Trial In MacroVascular Events) trial, assessing significant 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 alone for the primary endpoint, there was no increase in mortality or total macrovascular events with ACTOS. This safety information has been included in both the FDA-approved product label and EMA-approved Summary of Product Characteristics (SPC) since 2007, providing patients and health care professionals with additional relevant information regarding the CV safety profile of ACTOS.

Takeda is the inventor and developer of ACTOS, which was launched commercially in 1999. ACTOS, as labeled, is an effective and appropriate treatment option for many people living with type 2 diabetes. Certain patients with heart failure should not start taking ACTOS. ACTOS can cause new or worsen heart failure. 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.