Takeda Responds to FDA Advisory Committee Recommendation

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 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.

About ACTOS® (pioglitazone HCl) Indications and Usage

ACTOS is a prescription medication used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. ACTOS has been studied as a monotherapy and in combination with sulfonylurea, metformin, or insulin.

Important Safety Information

ACTOS is not for everyone. Certain patients with heart failure should not start taking ACTOS. ACTOS can cause new, or worsen, heart failure. Patients should talk to their doctor immediately if they experience unusually fast weight gain, fluid retention (swelling), shortness of breath, or unusual tiredness.

ACTOS is not for patients with type 1 "juvenile" diabetes or diabetic ketoacidosis.

ACTOS may cause low blood sugar when taken in combination with insulin or other oral antidiabetic drugs. Lightheadedness, shakiness, dizziness, or hunger may mean that a patient's blood sugar is too low. Patients should talk to their doctor if low blood sugar is a problem for them.

Some people taking ACTOS may experience flulike symptoms, mild-to-moderate swelling of legs and ankles, anemia, and weight gain.

If a patient is of childbearing age, they should talk to their doctor before taking ACTOS, as it could increase their chance of becoming pregnant. Patients should talk to their doctor if they are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed.

A patient should not take ACTOS if they have active liver disease. A doctor should perform a blood test to check for liver problems before a patient starts ACTOS and periodically thereafter. Patients should talk to their doctor immediately if they experience nausea, vomiting, stomach pain, unusual tiredness, loss of appetite, dark urine, or yellowing of the skin or eyes.

Patients with diabetes should have regular eye exams. If a patient experiences vision problems, they should consult with their doctor immediately. Some patients have experienced visual changes while taking ACTOS. Some people, particularly women, are at higher risk of having bone fractures while taking ACTOS. Other side effects may include cold-like symptoms, headache, sinus infection, muscle pain, tooth disorder, and sore throat.

Individuals are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For Complete Prescribing Information, including warnings about heart failure and Medication Guide, please visit www.ACTOS.com.

Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc.

Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology and gastroenterology treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for diabetes, cardiovascular disease, gastroenterology, neurology and other conditions. To learn more about these Takeda companies, visit www.tpna.com.

Takeda Pharmaceutical Company, Ltd.

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 strive towards better health for patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.

SOURCE Takeda Pharmaceuticals North America, Inc.