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Canada Approves Xenical (Orlistat) for Treatment of Excess Weight/Obesity in Type 2 Diabetes

MISSISSAUGA, ON -- February 11, 2002 -- Hoffmann-La Roche Limited today announced that Xenical® (orlistat) has been approved by Health Canada for use in combination with antidiabetic agents to improve blood glucose control in overweight or obese type 2 diabetes patients.

Xenical is the first weight management drug to receive this approval from Health Canada.

Approximately 90 percent of all people in Canada with diabetes have type 2 diabetes. Eighty to 90 percent of these patients are overweight or obese, and weight is the most significant modifiable risk factor in patients with type 2 diabetes. This new approval follows Health Canada's Priority Review of Xenical, which was undertaken over a 180-day period, as opposed to 300 days for a standard review.

"The approval of Xenical for use with overweight or obese type 2 diabetes patients is very good news for the over 1.8 million Canadians living with this serious disease as it will allow physicians to address one of the core issues associated with diabetes -- excess weight," said Dr. Shereen Ezzat, Associate Professor of Medicine, University of Toronto.

"Xenical is an excellent choice as a treatment option for overweight or obese patients with type 2 diabetes who have made a commitment to healthy eating and regular exercise but need additional assistance with weight management. In fact, a five to 10 percent weight reduction may improve blood sugar control and may also reduce or eliminate the need for additional antidiabetic medications," he added.

"The Canadian Diabetes Association welcomes any new treatment options that may assist someone with diabetes to manage the disease and/or related complications. This is especially important given that the prevalence of diabetes in Canada, specifically type 2 diabetes, is expected to double over the next decade," said Donna Lillie, Director, Research and Professional Education, Canadian Diabetes Association.

"The Canadian Diabetes Association encourages individuals with diabetes to discuss any new treatment option with their physician to determine the appropriateness of particular treatments to their individual situation," she said.

Clinical studies with Xenical in overweight or obese patients with diabetes have shown that those taking Xenical lost up to three times more weight than those on diet alone. More overweight or obese patients with type 2 diabetes taking Xenical had clinically significant improvements in blood sugar control than those on diet alone. Xenical significantly improves fasting plasma glucose in overweight or obese patients with type 2 diabetes as early as two weeks of starting treatment and it may reduce the need for antidiabetic medications in overweight patients with type 2 diabetes. Additional data has also shown that Xenical can improve certain risk factors for cardiovascular disease, such as cholesterol levels and blood pressure in diabetic patients.

SOURCE: Hoffmann-La Roche Limited

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