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FDA Approves GlaxoSmithKline's Avandamet™ (rosiglitazone maleate and metformin HCl), The Latest Advancement in the Treatment of Type 2 Diabetes

PHILADELPHIA, PA -- October 11, 2002 -- GlaxoSmithKline announced today 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 exciting 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," said Barry Goldstein, M.D., Ph.D., Director, Division of Endocrinology, Diabetes and Metabolic Diseases, Jefferson Medical College of Thomas Jefferson University, Philadelphia. "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."

Type 2 diabetes is characterized by high blood sugar levels that occur when the body cannot make enough insulin and/or respond normally to the natural insulin it makes (a condition called insulin resistance). In patients with type 2 diabetes, beta cells (the cells that make and release insulin in the pancreas) may become overworked and eventually fail, producing less insulin. This may lead to increased blood sugar levels and progressive worsening of the disease. When blood sugar levels are elevated over an extended period of time, serious complications can result, including cardiovascular disease, kidney damage and blindness. To reach blood sugar levels recommended by experts, many people with type 2 diabetes will need to take a combination of therapies that treat the disease in different ways.

"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," said David Brand, Vice President of Metabolic/Endocrine Marketing, GlaxoSmithKline U.S. "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. This combination of rosiglitazone and metformin offers the opportunity to help people manage their type 2 diabetes longer."

Avandamet: The Latest Advancement in Diabetes Management

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."

Safety Information

A small number of people who have taken metformin, one of the components of Avandamet, have developed a serious yet rare condition called lactic acidosis (a buildup of lactic acid in the blood). Lactic acidosis occurs most often in people with kidney problems and can be fatal in up to one half of the cases. In addition, rosiglitazone (another component of Avandamet) may cause fluid retention, especially if it is used with insulin. If left unchecked, fluid retention could lead to or worsen heart failure.

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.

About GlaxoSmithKline

GlaxoSmithKline is committed to providing innovative treatment options for people with diabetes and researching new potential therapies. AvandiaŽ (rosiglitazone maleate) is the number one prescribed TZD in the United States, with retail prescriptions surpassing 20 million. GlaxoSmithKline takes pride in offering both Avandia and Avandamet as part of the treatment arsenal for type 2 diabetes.

GlaxoSmithKline, with U.S. operations in Philadelphia, PA, and Research Triangle Park, NC, is one of the world's leading research-based pharmaceutical and healthcare companies and is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For more information on Avandamet, visit <http://www.avandamet.com> or call 1-888-825-5249.

SOURCE: GlaxoSmithKline

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