Roche has announced that the European Commission has approved an extension to the prescribing label for its weight loss medication Xenical. The extension will include the information that Xenical can reduce the risk for developing type 2 diabetes.
In addition, new information weight loss, long-term safety and tolerability has also been approved.
The Commission's decision was based on the results of the landmark XENDOS study, which showed for the first time that 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.
|Xenical can significantly 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 losing weight with lifestyle changes alone.
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.