First European Launch Of Xenical In September

Roche's lipase inhibitor for the treatment of obesity, Xenical(orlistat), has been given approval by the European Medicines Evaluation Agency, and will be launched in Germany, France, the UK, Austria and Finland in September. The labeling for the drug does not include a reference to the data suggesting a link to breast cancer, which is stalling the drug's approval in the USA. Xenical is currently marketed in New Zealand, Argentina, the Far East and Latin America.

Approvability status was given in mid-May in the USA, where Roche says it is hoping to receive full Food and Drug Administration approval in the first quarter of 1999 (Marketletter June 22). In New Zealand, where the drug was first launched in May with a clean label for the breast cancer link, preliminary experience shows no indication of a raised risk of breast cancer.

Efficacy In Obese Diabetics Demonstrated Meanwhile, the Ruth Collins Diabetes Center at Baylor University in Houston, USA, has reported the results of a randomized, placebo-controlled multi-center study of 391 obese men and women with type 2 diabetes under treatment with oral sulfonylureas. The researchers found that twice as many patients given 120mg Xenical three times a day lost 5% of their body weight compared to those given placebo.