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SNDA FILED FOR XENICAL AS TYPE 2 DIABETES TREATMENT OPTION.

Roche, Mississauga, ON, Canada, has announced that a supplemental New Drug Application (sNDA) has been submitted to the U.S. Food and Drug Administration (FDA) for Xenical (orlistat), as an adjunct to other anti-diabetic medications for the treatment of type 2 diabetes in patients who are overweight or obese. This is important because almost 90 percent of patients with type 2 diabetes are overweight or obese and weight is the most important modifiable risk factor in patients with type 2 diabetes. In Canada, a submission regarding type 2 diabetes will be made to Health Canada in the near future.

Xenical is a unique weight management treatment that acts locally by preventing fat being absorbed in the gut. Xenical not only helps patients lose weight, it also encourages more healthy eating habits, thus helping them maintain their weight loss.

Clinical studies with Xenical in diabetes have shown the following:

- overweight and obese patients with type 2 diabetes taking Xenical lost up to three times more weight than those on diet alone;

- Xenical patients had clinically significant improvements in blood sugar control;

- more patients treated with Xenical were able to reduce the dose of, or even discontinue their anti-diabetic medications; and,

- additional data have also shown that Xenical can improve certain risk factors for cardiovascular disease, such as total cholesterol levels and blood pressure in diabetic patients.

Type 2 diabetes is a major global public health problem with the incidence and prevalence of diabetes escalating towards a world-wide epidemic. In Canada, over two million people have diabetes and that number is expected to double by the end of the decade. Of that number, approximately 90 per cent will be type 2 diabetes cases.

Many other countries report a similar experience and it has been estimated that, on a global level, almost 300 million people could have type 2 diabetes by the year 2025. The major underlying cause of this diabetes epidemic is the increasing prevalence of obesity. Type 2 diabetes is associated with a high risk of several complications that may lead to premature cardiovascular morbidity and mortality. Weight management is the first-line treatment of type 2 diabetes. Even a modest reduction of initial body weight improves blood sugar control in patients with type 2 diabetes and also reduces the severity of cardiovascular risk factors such as high cholesterol levels and high blood pressure.

About Xenical

Xenical has been available in Canada since June, 1999. It is an effective and safe therapy that not only helps patients lose weight, but also helps them maintain their weight loss. It is the only available weight loss medication that works locally in the gut to prevent dietary fat absorption by about 30 percent. Xenical is well tolerated, and unlike other weight loss medications, it does not act on the central nervous system. In clinical trials, people taking Xenical in conjunction with a mildly reduced calorie diet have shown twice as much weight loss as diet alone. Xenical is covered by a number of private insurance companies as a viable and effective treatment option available to assist people in losing weight and has also been submitted for provincial coverage across Canada.

About Hoffmann-La Roche Limited

F. Hoffmann-La Roche Limited is an international healthcare company committed to the discovery and development of new and innovative medicines to help treat human illnesses. Represented in more than 70 countries, the company is a world leader in the research and development of innovative pharmaceuticals, vitamins, fine chemicals and diagnostic equipment. The company is active in a broad range of therapeutic categories that include: AIDS, cardiology, dermatology, hepatitis C, infectious disease, metabolism, oncology and transplant.

For more information, call (416)979-1120 ext. 329/237.
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Publication:Worldwide Biotech
Date:May 1, 2001
Words:613
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