Takeda Pharmaceuticals North America today
announced that the company has submitted a New Drug Application (NDA) for a
new oral medication that combines pioglitazone HCl and glimepiride, a
sulfonylurea, to the United States Food and Drug Administration (FDA) for
the treatment of type 2 diabetes. Takeda submitted a separate NDA for a
combination of pioglitazone HCl and metformin HCl in October 2004.
ACTOS® (pioglitazone HCl) directly targets insulin resistance, a
condition in which the body does not efficiently use the insulin it
produces. Glimepiride 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. The
company is seeking approval to bring the medication to market in the United
States.
According to the American Diabetes Association, diabetes affects an
estimated 18.2 million Americans. Type 2 diabetes is the most common form,
and may account for about 90 to 95 percent of all diagnosed cases of
diabetes.
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 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 type 2 diabetes for use
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 glucose.
About glimepiride
Glimepiride is a prescription blood glucose-lowering drug of the
sulfonylurea class. Side effects seen with glimepiride include hypoglycemia
(blood glucose of < 60 mg/dL), which may become more severe. Patients
taking glimepiride should be aware of the signs and symptoms of
hypoglycemia which may include shakiness, nervousness, sweating, hunger,
headache, nausea, asthenia (loss of strength) and dizziness.
Glimepiride should not be taken by patients with hypersensitivity to the
drug or with diabetic ketoacidosis. Glimepiride should be discontinued in
nursing mothers. Administration of an oral hypoglycemic drug similar to
glimepiride has been associated with increased cardiovascular mortality as
compared to treatment with diet and exercise alone or diet plus insulin.
Patients should always talk with their health professional about all the
prescription and over-the-counter medications and dietary supplements they
are taking before starting a new prescription.
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 <http://www.tpna.com>
ACTOS is a registered trademark of Takeda Pharmaceutical Company, Limited
and used under license by Takeda Pharmaceuticals North America, Inc.
Contacts:
Dave Buckalew
Takeda Pharmaceuticals North America
847 383 3904
Amy Losak
Ketchum
646 935 3917