Roche’s anti-obesity medicine, Xenical (orlistat), has won the green light from the European regulator for use in obese adolescents aged 12 years and over.
The move comes on the back of recent trial results, which showed Xenical to be highly effective in helping obese young people to lose weight. The study, which was published in the Journal of the American Medical Association, included some 539 obese adolescents who received either 120mg Xenical or placebo three times daily, alongside a reduced-calorie diet and exercise for one year. Weight loss was tracked using changes in body mass index, which takes into account not only the changes in body weight but also the changes in height that occur in growing adolescents. Those receiving Xenical had a significantly reduced BMI versus placebo (a decrease of 0.55 kg/m2 compared to an increase of 0.31 kg/m2 in the placebo group), and almost twice as many adolescents treated with Xenical reduced their BMI by at least 5% (27% versus 16%) and their body weight (19% versus 12%). In addition, adolescents treated with Xenical had a greater decrease in body fat and waist circumference, with the latter actually increasing amongst placebo receivers.
Roche notes that there has been a significant increase in obesity in children and adolescents in Europe over the past few years, with as many as one in four affected in some regions. Obese children tend to become obese adults, and they carry a high risk of acute and chronic diseases, leading to reduced life expectancy and treatment and prevention of childhood obesity has been identified as a healthcare priority in Europe.
This latest approval will likely give Xenical an added boost. The product experienced flagging sales last year – down 2% to 593 million francs in 2004 [[02/02/05a]], following a 13% dip a year earlier to 613 million Swiss – but has had its approval expanded into glucose intolerance [[01/11/04f]], as well as adolescent obesity. Furthermore, Roche has hooked up with GlaxoSmithKline to sell the drug in the USA [[13/04/05b]].