European Commission approves Xenical label extension
The European Commission has approved an extension to the prescribing label for Roche's weight loss medication Xenical to include new information that the drug can reduce the risk for developing type 2 diabetes. New information on four year data on weight loss, long-term safety and tolerability has also been approved.
The European Commission has approved an extension to the prescribing label for Roche's weight loss medication Xenical to include new information that the drug can reduce the risk for developing type 2 diabetes. New information on four year data on weight loss, long-term safety and tolerability has also been approved.
The decision was based on the results of the XENDOS study, which showed for the first time that Xenical can significantly reduce the risk of developing type 2 diabetes.1 The study also confirmed a significant and sustained weight loss over the long term. XENDOS showed that losing weight with Xenical reduced the risk of developing diabetes by 37% compared with losing weight with lifestyle changes alone, and by 52% in patients with impaired glucose tolerance.
'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.