Public Release: 

Reduced risk for developing type 2 diabetes recommended for inclusion in Xenical's European label

Shire Health International

Roche announced today that the European Union's Committee for Proprietary Medicinal Products (CPMP) has given a positive recommendation to extend the European label for its weight loss medication Xenical® to include:

  • four year data on weight loss;
  • long-term safety and tolerability profile; and
  • reduced risk for developing type 2 diabetes.

    The decision is based on the results of the landmark XENDOS (XENical in the prevention of Diabetes in Obese Subjects) study, which showed for the first time that a weight loss medication could significantly reduce the risk of developing type 2 diabetes.

    XENDOS is the largest and longest study of a weight loss medication, treating 3304 patients for four years with Xenical plus lifestyle changes, or lifestyle changes alone. It is also the first study to assess whether treatment with a weight loss medication, Xenical, can reduce the risk of developing type 2 diabetes. The study showed that losing weight with Xenical reduced the risk of developing diabetes by 37% compared with lifestyle changes alone and by 52% in patients with impaired glucose tolerance (IGT or pre-diabetes). Compared to lifestyle changes alone, Xenical treatment produced significantly greater long-term weight loss and improvements in cardiovascular risk factors (including blood pressure and lipids). The study also confirmed that Xenical has a long-term safety profile that is unmatched in the field of weight loss.

    "The CPMP's decision is an important step towards expanding the European label for Xenical, which we believe will provide physicians with an effective strategy for helping patients lose weight and thereby delaying or preventing type 2 diabetes," commented Dr. Paul Brown, Life Cycle Leader for Xenical.

    The CPMP's positive opinion will now be proposed for approval by the European Commission.

    Type 2 diabetes

    Health experts have warned of a global epidemic of diabetes caused by a rise in overweight and obesity. There are currently 120-140 million people worldwide with type 2 diabetes, and if trends continue, this number is predicted to double in the next 25 years.2 More than 90% of all people with type 2 diabetes are overweight or obese.3 Because of the severe health and cost implications of type 2 diabetes, organisations such as the International Diabetes Federation (IDF) have called for increased efforts to prevent the development of type 2 diabetes. The IDF estimates that 314 million people worldwide, or 8.2% of the global population, have impaired glucose tolerance, a state that often precedes type 2 diabetes.

    Excess weight

    Excess weight is well recognised as the most important modifiable risk factor for the development of type 2 diabetes. A number of recent studies have shown that lifestyle changes (diet and exercise) have a dramatic effect on delaying or preventing the development of type 2 diabetes.5, 6 The XENDOS study represents an important step forward in the evolution of diabetes prevention studies through the study design and the outcomes that were measured.

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    Notes to Editors:

    About Xenical

    Xenical is the only available weight loss medication that works locally in the gut to prevent dietary fat absorption by around 30% to effectively promote weight loss. It is an effective therapy that not only helps patients lose weight, but also helps them maintain their weight loss. Xenical is well tolerated and unlike appetite suppressants, it does not act on the brain. Since it was first marketed in 1998, there have been more than 18.5 million patient treatments with Xenical worldwide. Xenical is licensed for weight management in over 140 countries around the world. For further information please go to: www.managingyourweight.com

    About Xenical Weight Management Programmes

    Roche has developed Xenical Weight Management Programmes (WMPs) for healthcare professionals to use with their patients. The programme aims to help patients set and reach realistic weight goals while modifying their dietary intake and behaviour in the long-term. The programmes are individually tailored to help people achieve their weight loss goals, and maintain weight loss, through healthy eating, physical activity and pharmacotherapy.

    Roche provides the WMP free of charge in around 50 countries worldwide to offer additional support to patients treated with Xenical. Recent data demonstrated that patients enrolled in Xenical WMPs can significantly improve the levels of weight loss achieved and can increase their overall satisfaction and compliance with treatment.

    About Roche

    Headquartered in Basel, Switzerland, Roche is one of the world's leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is number one in the global diagnostics market, the leading supplier of pharmaceuticals for cancer and a leader in virology and transplantation. As a supplier of products and services for the prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche employs roughly 65,000 people in 150 countries. The Group has alliances and R&D agreements with numerous partners, including majority ownership interests in Genentech and Chugai.

    All trademarks used or mentioned in this release are legally protected.

    For further information please contact:

    Liz GoftonShire Health InternationalOffice Phone: 44-207-471-1518 E-mail: liz.gofton@shirehealthinternational.com
    Patrick WardShire Health InternationalMobile Phone: 44-797-087-2427 E-mail: patrick.ward@shirehealthinternational.com

    References:

    1. Torgerson JS, et al. XENDOS: a randomised study of orlistat as an adjunct to lifestyle changes for the prevention of type 2 diabetes in obese patients. Diabetes Care 2004;27(1):155-61
    2. World Health Organization. Health Topics. http://www.who.int/health_topics/diabetes_mellitus/en/
    3. Colditz GA, Willett WC, Rotnitzky A, Manson JE. "Weight gain as a risk factor for clinical diabetes mellitus in women". Ann Inter Med (1995). 122:481-486.
    4. International Diabetes Federation. New Diabetes Figures. http://www.idf.org/home/index.cfm?node=1054
    5. Tuomilehto et al. Diabetes Prevention Study (DPS). NEJM, May 3, 2001, Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance.
    6. Diabetes Prevention Program (DPP). NEJM, February 7, 2002. Reduction in the incidence in type 2 diabetes with lifestyle intervention or metformin.

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