LINCOLNSHIRE, Ill., April 3, 2006 – Takeda Global Research & Development Center (TGR&D) today announced that the company has submitted a New Drug Application (NDA) for an extended-release version of the combination medication ACTOplus met™(pioglitazone HCl and metformin HCl) to the United States Food and Drug Administration (FDA) for the treatment of type 2 diabetes. This new formulation (ACTOplus met XR) would allow for once-daily dosing, while ACTOplus met (immediate release) is already available, being marketed by Takeda Pharmaceuticals North America, Inc.
ACTOplus met is an oral medication that combines ACTOS® (pioglitazone HCl), which directly targets insulin resistance – a condition in which the body does not efficiently use the insulin it produces – with metformin, which acts primarily by reducing the amount of glucose produced by the liver. These medications work in combination to help patients with type 2 diabetes manage their blood glucose levels.
The NDA submission represents yet another milestone for Takeda, following the FDA approval of ROZEREM™ (ramelteon).
“We are certainly proud of this NDA submission, and the ACTOS portfolio of products,” said John Yates, M.D., president of TGR&D. “Not all patients are alike, especially in diabetes, and the addition of this new product would provide patients and their physicians with more options and greater flexibility, while continuing to provide the benefits of treatment with ACTOS.”
Extended-release metformin, one of the active ingredients in ACTOplus met XR, was developed by Andrx Corporation. Takeda Pharmaceutical Company Limited signed an agreement with Andrx Corporation covering extended-release metformin in December 2003.
About ACTOplus met
A small number of people who have taken metformin, a component of ACTOplus met™(pioglitazone HCl and metformin HCl), have developed a rare, serious condition called lactic acidosis. Lactic acidosis, a buildup of lactic acid in the blood, can be fatal in about half the cases. Because lactic acidosis occurs most frequently in people with kidney problems, ACTOplus met should not be used in people with kidney disease or in people 80 years of age and older whose kidneys do not work properly. ACTOplus met should not be taken by people with metabolic acidosis, or with hypersensitivity to pioglitazone, metformin or any other component of ACTOplus met. ACTOplus met should not be taken by people who drink excessive alcohol. ACTOplus met should be discontinued in patients with severe infection or in patients undergoing x-ray studies using intravenous contrast dye.
ACTOS® (pioglitazone HCl) and ACTOplus met can cause fluid retention (swelling) 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 either drug. If you have moderate to severe heart failure, ACTOS or ACTOplus met is not recommended. Your doctor should perform a blood test to check for liver problems before you start ACTOS or ACTOplus met and periodically thereafter. Do not take ACTOS or ACTOplus met 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 or ACTOplus met as it could increase your chance of becoming pregnant.
ACTOplus met is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes who are already treated with a combination of pioglitazone and metformin or whose diabetes is not adequately controlled with metformin alone.
ACTOS is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. ACTOS may be used alone or in combination with metformin, sulfonylureas, or insulin.
Neither ACTOS nor ACTOplus met should be used in type 1 diabetes. For more information about Actoplus met, including complete prescribing information, talk to your pharmacist or health professional, or go to 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 and cholesterol-lowering treatments. Through the Takeda Global Research & Development Center, Inc., the company has a robust pipeline with compounds in development for diabetes, sleep, cardiovascular disease and other conditions. Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. To learn more about the company and its products, visit www.tpna.com.
ACTOS, ACTOplus met, and ROZEREM are registered trademarks of Takeda Pharmaceutical Company Limited and used under license by Takeda Pharmaceuticals North America, Inc.
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