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New Drug Application for Pioglitazone, Metformin Combination Submitted

LINCOLNSHIRE, Ill., Oct. 29 /PRNewswire/ -- Takeda Pharmaceuticals North America today announced that the company has submitted a New Drug Application (NDA) for Actoplus Met™ to the United States Food and Drug Administration (FDA) for the treatment of type 2 diabetes. This is the second NDA submission for Takeda in the past 45 days (an NDA for ramelteon was submitted in September).

This oral medication combines ACTOS® (pioglitazone HCl), which directly targets insulin resistance -- a condition in which the body does not effectively 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 company is seeking approval to bring Actoplus Met to market in the United States.

"We are certainly proud of the Actoplus Met NDA submission, not only because it marks a milestone for the ACTOS portfolio and for Takeda, but also because it is an important new option for people with type 2 diabetes by combining two medications proven to support and complement the management of this chronic disease," said Mark Booth, president of Takeda Pharmaceuticals North America.

According to the American Diabetes Association, type 2 is the most common form of diabetes, affecting an estimated 17 million Americans.

About ACTOS

ACTOS, an insulin sensitizer belonging to the thiazolidinedione (TZD) class of oral antidiabetic medications, directly targets insulin resistance, a condition in which the body does not effectively 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 as monotherapy to lower blood glucose and in combination therapy with insulin, sulfonylureas or metformin.

Additional Information

ACTOS® (pioglitazone HCl) is not for everyone. ACTOS can cause fluid retention or edema (swelling), which 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, edema (swelling), or shortness of breath while taking ACTOS. If you have moderate to severe heart failure, ACTOS is not recommended.

Also, your doctor should perform a blood test to check for serious liver problems or active liver disease before you start ACTOS and regularly thereafter. Do not take ACTOS if you have active liver disease. Talk to your doctor immediately if you experience nausea, vomiting, stomach pain, tiredness, anorexia, dark urine, or yellowing of the skin. If you are of childbearing age, talk to your doctor before taking ACTOS because it could increase your chance of becoming pregnant.

Some people taking ACTOS may experience cold and flu-like symptoms, mild to moderate swelling of legs and ankles, and anemia. Occasionally, blood sugar levels increased during clinical trials. When taking ACTOS with insulin or sulfonylureas, you may be at risk for low blood sugar. Please visit the ACTOS Web site at http://www.actos.com/ for complete ACTOS Prescribing Information.

About metformin

Metformin, a biguanide, lowers blood glucose levels primarily by decreasing the amount of glucose produced by the liver. Metformin also helps to lower blood glucose levels by making muscle tissue more sensitive to insulin so glucose can be absorbed.

A small number of people who have taken metformin have developed a serious condition called lactic acidosis that has been fatal in up to 50% of cases. Lactic acidosis has occurred most often in people whose kidneys were not working properly. Liver problems may also increase the risk of developing lactic acidosis. Stop taking metformin and call your doctor immediately if you experience a feeling of general discomfort or sickness; weakness; sore or aching muscles; trouble breathing, unusual drowsiness, dizziness or lightheadedness; unusual or unexplained stomach upset (after the initial stomach upset that may occur at the start of therapy with metformin); or the sudden development of a slow or irregular heartbeat. These may be signs of lactic acidosis.

Avoid excessive alcohol intake while taking metformin. Together, alcohol and metformin may increase the risk of lactic acidosis and hypoglycemia. Metformin does not usually cause hypoglycemia (low blood sugar). Nevertheless, hypoglycemia may occur, as a result of skipped meals, excessive exercise, or alcohol consumption. Know the signs and symptoms of low blood sugar, which include hunger, headache, drowsiness, weakness, dizziness, a fast heartbeat, sweating, tremor, and nausea. Carry candy or glucose tablets to treat episodes of low blood sugar. For further information on metformin, contact your health provider.

Source: Takeda Pharmaceuticals

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