PILL FOR TYPE 2 DIABETES APPROVED BY HEALTH CANADA.

Health Canada has approved Avandia (rosiglitazone maleate), a breakthrough treatment for type 2 diabetes. Avandia, developed by SmithKline Beecham, is the first drug available in Canada to directly treat insulin resistance, a major underlying factor in type 2 diabetes. The approval brings the promise of a better quality of life to 1.5 million Canadians diagnosed with diabetes, and 750,000 people currently undiagnosed.

"Avandia works in a significantly different fashion than currently available diabetes medications," said Dr. Lawrence Leiter, Professor of Medicine and Nutritional Sciences, University of Toronto and Director, Lipid Clinic, St. Michael's Hospital. "By directly decreasing insulin resistance, and allowing the body's own insulin to work more effectively, not only will Avandia help lower blood sugar levels, but it may also lower blood pressure and improve lipid (blood fat) levels, all of which should decrease the risk of heart disease," he added.

Insulin Resistance and Avandia - The Power to Control Diabetes

Insulin resistance is the body's failure to respond properly to its own insulin. It is associated with a number of risk factors, including high blood pressure, high cholesterol and high blood sugar which are known to affect progression to complications such as kidney failure, nerve damage and heart disease.

Avandia is a thiazolidinedione (TZD), and is the first treatment available in Canada in a new class of oral anti-diabetic agents that directly targets insulin resistance. Avandia, taken once a day, has been shown to be effective as both monotherapy and in combination with metformin, one of the most commonly used anti-diabetic agents.

"Diabetes is an incredibly complex disease. As this complexity is unraveled and knowledge is gained, new options, including drugs like Avandia, become increasingly important as they can more effectively align treatments," said Donna Lillie, Director, Research and Professional Education, Canadian Diabetes Association. "The Canadian Diabetes Association recommends that Canadians with diabetes discuss any new treatment option with their physician to determine if it is appropriate," she added.

Avandia Clinical Study Data

Health Canada approved Avandia based on a priority review of data from clinical studies involving more than 4,500 patients with type 2 diabetes. These studies have shown that Avandia effectively lowered blood sugar levels of patients by an average of up to 4.2 mmol/L compared to placebo, and maintained blood sugar control for up to 12 months. Ongoing observations show that Avandia continues to control blood sugar for at least 18 months. Avandia also showed beneficial improvements in reducing other risk factors associated with the development of diabetes-related complications.

Recently released data from the United Kingdom Prospective Diabetes Study (UKPDS) study, a 20-year study and the largest clinical study to date on diabetes, showed that improved blood sugar control can prevent diabetes-related complications like kidney disease. UKPDS data also demonstrated that currently available diabetes medications do not adequately sustain blood sugar control.

"We've been involved in a number of clinical trials with Avandia and our experience to date has been excellent. Many of our patients have had very dramatic reductions in their blood sugar levels, and this should translate into a significant reduction in long-term complications," said Dr. Leiter. "Treating insulin resistance early in the disease, before irreversible damage occurs, is an important goal of type 2 diabetes management, and Avandia provides the Canadian medical community with an effective alternative to currently available diabetes medications," he added.

"No other medication has controlled my blood sugar levels sufficiently like Avandia," said Neil Mosher, a patient with type 2 diabetes. "Today, my levels have come down significantly, and are now within normal range. I have more energy, I am less irritable and less worried about potential complications. Avandia has been a godsend," he added.

Worldwide Approval of Avandia

In addition to Canada's approval of the drug, Avandia has received marketing approval in 26 countries, including the United States where more than two million prescriptions have been written.

"We are delighted about the approval of Avandia. It represents a significant breakthrough for patients who have been calling for new and different ways to tackle their condition," said Eddie Gray, president of SmithKline Beecham Pharma. "What's important now is that all patients with type 2 diabetes have access to Avandia," he added.

SmithKline Beecham Pharma and its shareholders are committed to the research and development of innovative medicines to satisfy Canadians' demand for exceptional healthcare. By ensuring patients' access to, and optimal utilization of its products, SmithKline Beecham will grow its business by delivering value to participants within the Canadian healthcare system. The company's therapeutic areas include diabetes, psychiatric disorders, Parkinson's disease, vaccines, cancer treatments, shingles, herpes, infectious diseases and arthritis.

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