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Item #5 

FDA Approves GSK's Avandamet™ for Type 2 Diabetes Treatment

Another new treatment option for patients with Type 2 diabetes who are not in control.

GlaxoSmithKline announced last week that the U.S. Food and Drug Administration (FDA) approved Avandamet™ (rosiglitazone maleate and metformin HCl) for the treatment of type 2 diabetes, offering an new option for millions of Americans with the disease. Avandamet combines two leading diabetes medications in one convenient pill. This combination offers the opportunity to help people manage their type 2 diabetes longer. Avandamet will be available to patients in approximately one month.

"The combination of rosiglitazone and metformin provides two different, yet complementary mechanisms of action to manage diabetes. "Rosiglitazone targets insulin resistance, an underlying cause of type 2 diabetes, whereas metformin works to reduce the amount of blood sugar (or glucose) produced by the liver. The two medications, when used in combination, target core metabolic defects to help achieve better blood sugar control than metformin alone, making this an important option for patients with type 2 diabetes."

"GlaxoSmithKline is committed to developing novel diabetes therapies to treat a disease that has reached epidemic proportion in the United States and throughout the world," "With Avandamet, the latest addition to our diabetes portfolio, we hope to provide an effective, convenient treatment option for people suffering from uncontrolled type 2 diabetes and also to improve patient compliance”, said David Brand, Vice President of Metabolic/Endocrine Marketing, GlaxoSmithKline U.S.. This combination of rosiglitazone and metformin offers the opportunity to help people manage their type 2 diabetes longer."

The use of rosiglitazone and metformin together as separate tablets was first approved by the FDA in 1999 as safe and effective based on two controlled clinical trials in people with type 2 diabetes inadequately controlled on metformin alone. As an adjunct to diet and exercise, Avandamet is indicated to improve blood sugar control in people with type 2 diabetes who are already treated with rosiglitazone and metformin as separate tablets, or who are not adequately controlled on metformin alone. It is available in three tablet strengths of rosiglitazone/metformin, respectively: 1 mg/500 mg, 2 mg/500 mg and 4 mg/500 mg. The additive effect of the combination of rosiglitazone and metformin has been shown to significantly reduce A1C levels compared to metformin alone. A1C levels are the most effective measure of long-term blood sugar control. Additionally, it has been shown to successfully impact core defects of type 2 diabetes, resulting in improvements in both insulin resistance and estimates of beta-cell function.

In fact, research has demonstrated that rosiglitazone and metformin in combination significantly reduces and maintains blood sugar levels for up to two years. The combination has been associated with a low risk of hypoglycemia (low blood sugar). Avandamet, as a two-in-one therapy, is the most economical thiazolidinedione (TZD) combination on the market, offering simplified dosing.

Importance of Aggressive Diabetes Management

Diabetes experts are setting more stringent standards that reflect the importance of maintaining tight glucose control. Based on the United Kingdom Prospective Diabetes Study (UKPDS) showing that tight blood sugar control can delay or prevent the complications of type 2 diabetes, the American Diabetes Association has established an A1C level of no more than 7.0 percent as the therapeutic target. However, recently, the American Association of Clinical Endocrinologists and the American College of Endocrinology proposed an A1C target of 6.5 percent to help reduce the frequency of complications.

"More than 50 percent of people diagnosed with type 2 diabetes do not meet target A1C levels. And, with every one percent above target A1C levels, a person's risk for diabetes complications, such as cardiovascular disease, increases," said Hossein Gharib, M.D., FACE, President of the American Association of Clinical Endocrinologists. "Therefore, it is critical that we work to manage diabetes early and aggressively to help ensure that blood sugar levels are in control."

Avandamet is not indicated for use with insulin. Avandamet should not be used in patients with renal disease or dysfunction or with congestive heart failure requiring medication. Before using Avandamet, patients over the age of 80 should have their renal function tested to assure that their kidney function is adequate. Avandamet is not recommended for people with liver disease. Patients should inform their doctor if they drink alcohol excessively. Tests should be conducted before and while taking Avandamet to check for liver problems.

 For more information on Avandamet, visit <http://www.avandamet.com> or call 1-888-825-5249. SOURCE: GlaxoSmithKline

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