Roche announced that the European Commission has approved an extension to the prescribing label for its weight loss medication Xenical to include new information that Xenical can reduce the risk for developing type 2 diabetes. In addition, new information on four year data on weight loss, long-term safety and tolerability has also been approved.
A positive opinion for the label extension was received from the Committee for Proprietary Medicinal Products (CPMP) in January this year. The decision was based on the results of the landmark Xendos study, which showed for the first time that the weight loss medication Xenical can significantly reduce the risk of developing type 2 diabetes. The study also confirmed a significant and sustained weight loss over the long term.
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 the 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 per cent compared with losing weight with lifestyle changes alone and by 52 per cent 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 decision to extend Xenical's label is an important step forward as it provides physicians with an effective strategy for managing excess weight and delaying or preventing type 2 diabetes." commented William M. Burns, head of the pharmaceutical division at Roche.
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. More than 90 per cent of all people with type 2 diabetes are overweight or obese. 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 per cent of the global population, have impaired glucose tolerance, a state that often precedes type 2 diabetes.
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. 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.
Xenical is the only available weight loss medication that works locally in the gut to prevent dietary fat absorption by around 30 per cent 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.
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.