LINCOLNSHIRE, Ill., July 28, 2006 –Takeda Pharmaceuticals North America, Inc. (TPNA) today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Duetact ™ (pioglitazone HCl and glimepiride), pronounced “Duet Act,” for the treatment of type 2 diabetes.
Duetact combines ACTOS®(pioglitazone HCl) and glimepiride, two widely used diabetes
medications with complementary actions , in a single tablet. ACTOS directly targets insulin resistance, a condition where the body does not efficiently use the insulin it produces; and glimepiride, a sulfonylurea, acts primarily by increasing the amount of insulin produced by the pancreas. These medications work in combination to help patients with type 2 diabetes manage their blood glucose levels.
According to the American Diabetes Association, diabetes affects more than 18 million people in the U.S., and type 2 diabetes is the most common form of the disease. Both ACTOS and glimepiride are widely used medications in the treatment of type 2 diabetes, and both have a known safety profile. Combining these medications may provide patients with an easier way to take the two drugs, as diabetic patients are often prescribed multiple medications to help manage the disease.
“Takeda is committed to developing optimal treatment options for healthcare providers and their
patients,” said Mark Booth, president of Takeda Pharmaceuticals North America, Inc. “Duetact is another sign of that commitment by offering a new and convenient option for people with type 2 diabetes and another important new addition to the ACTOS portfolio.”
To offer physicians greater flexibility in treating their patients’ needs, duetact will be available in two commonly used dosages of pioglitazone and glimepiride to be taken once daily — 30 mg /2 mg and 30 mg /4 mg as mentioned in the approved labeling. Takeda expects the medication to be available to patients later this year.
Duetact, along with diet and exercise, helps improve blood sugar control in type 2 diabetes. Duetact is a combination of two drugs – pioglitazone hydrochloride and glimepiride.
Duetact may cause low blood sugar. Lightheadedness, dizziness, shakiness, or hunger may mean that your blood sugar is too low. Talk to your doctor if low blood sugar is a problem for you. Duetact may cause fluid retention or swelling, which could lead to or worsen heart failure, so you
should tell your doctor if you have a history of these conditions. If you experience an unusually rapid increase in weight, swelling, or shortness of breath while taking duetact, talk to your doctor immediately. Duetact is not recommended for patients with moderate to severe heart failure. Duetact is not recommended for patients with liver disease. Blood tests should be used to check for liver problems before starting and while taking duetact. Tell your doctor if you have liver disease, or if you experience unexplained tiredness, loss of appetite, stomach problems, dark urine, or yellowing of skin while taking duetact.
If you are nursing, do not take duetact. If you are pregnant or thinking about becoming pregnant, talk to your doctor before taking duetact. Duetact may increase your risk of becoming pregnant.
Some people in clinical trials experienced upper respiratory infections, weight gain, edema (swelling), hypoglycemia, and headache while taking the combination of drugs in duetact. Your doctor should check your eyes regularly. Very rarely, some patients have experienced vision changes while taking glimepiride, a component of duetact.
For Complete Prescribing Information for duetact or ACTOS, visit www.actos.com .
Takeda Pharmaceuticals North America, Inc .
Based in Lincolnshire, Ill., Takeda Pharmaceuticals North America, Inc., is a wholly owned
subsidiary of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. In the United States, Takeda currently markets oral diabetes, insomnia, cholesterol-lowering and gastroenterology treatments, and through the Takeda Global Research & Development Center, Inc., the company has a robust pipeline with compounds in development for diabetes, cardiovascular disease and other conditions. Takeda is committed to striving toward better health for individ uals and progress in medicine by developing superior
pharmaceutical products. To learn more about the company and its products, visit www.tpna.com . For further information on glimepiride, contact your pharmacist or health provider.
ACTOS and duetact are trademarks of Takeda Pharmaceutical Company Limited and used under license by Takeda Pharmaceuticals North America, Inc.
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