Takeda Responds to the FDA Advisory Committee Recommendation

Jul 30, 2007, 01:00 ET from Takeda

    DEERFIELD, Ill., July 30 /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, both prospective and observational, studies in both humans and
 animals, all have shown no evidence that ACTOS is associated with an
 increased risk of heart attack or stroke," said Mehmood Khan, M.D., TGRD
 president. "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 there was no statistically significant
 difference between ACTOS and standard of care for the primary endpoint,
 there was no increase in mortality or total macrovascular events with
     The ACTOS Prescribing Information was recently revised by the FDA 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. Khan.
 "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
     About ACTOS
     ACTOS works by directly targeting insulin resistance, a condition in
 which the body does not efficiently use the insulin it produces to control
 blood glucose levels. ACTOS is taken once daily as an adjunct to diet and
 exercise, and is approved for use for type 2 diabetes as monotherapy to
 lower blood glucose and in combination therapy with insulin, sulfonylureas
 or metformin.
     Additional Information
     ACTOS is not for everyone. ACTOS can cause fluid retention that may
 lead to or worsen heart failure, so tell your doctor if you have a history
 of these conditions. Talk to your doctor immediately if you experience
 rapid weight gain, fluid retention, or shortness of breath while taking
 ACTOS. If you have moderate to severe heart failure, ACTOS is not
 recommended. Your doctor should perform a blood test to check for liver
 problems before you start ACTOS and periodically thereafter.
     Do not take ACTOS if you have active liver disease. Talk to your doctor
 immediately if you experience nausea, vomiting, stomach pain, tiredness,
 loss of appetite, dark urine, or yellowing of the skin. If you are of
 childbearing age, talk to your doctor before taking ACTOS as it could
 increase your chance of becoming pregnant. Some people taking ACTOS may
 experience flu-like symptoms, mild to moderate swelling of legs and ankles,
 and anemia. When taking ACTOS with insulin or sulfonylureas, you may be at
 risk for low blood sugar. Patients with diabetes should have regular eye
 exams. If you experience vision problems, consult your doctor immediately.
 Very rarely, some patients have experienced visual changes while taking
     Please visit the ACTOS Web site at www.actos.com for Complete
 Prescribing Information.
     Takeda Global Research & Development Center, Inc.
     Based in Deerfield, Ill., and London, U.K., Takeda Global Research &
 Development Center, Inc. is a wholly owned subsidiary of Takeda
 Pharmaceutical Company Limited, the largest pharmaceutical company in
 Japan. Takeda Global Research & Development was established in 2004 and is
 responsible for Takeda's clinical research and development in the U.S. and
 Europe, supporting clinical and product development activity for Takeda
 commercial organizations in the U.S. - Takeda Pharmaceuticals North
 America, Inc, and in Europe: six sales and marketing companies,
 respectively. With a robust pipeline of compounds in development for
 diabetes, cardiovascular disease and other conditions, Takeda rapidly
 brings innovative products to market to improve patient health and enhance
 the practice of medicine. To learn more about the company, visit
     ACTOS(R) (pioglitazone HCl) is a registered trademark of Takeda
 Pharmaceutical Company Limited and used under license by Takeda
 Pharmaceuticals North America, Inc.