Roche applies for antidiabetic licence

Roche has applied to the FDA for permission to market orlistat (Xenical) for use as an antidiabetic.

The drug, licensed in April 1999 for weight loss in conjunction with a reduced calorie diet, is a gastrointestinal lipase inhibitor which prevents one-third of dietary fat from being absorbed.

Roche has found that it can also improve glycaemic control when used alongside other antidiabetic treatments in overweight and obese patients with Type II diabetes.

As well as proving the weight loss action, clinical trials showed that orlistat had a significantly greater effect in decreasing glycosylated haemoglobin and fasting plasma glucose levels compared to patients treated with placebo.

In addition, patients with Type II diabetes treated with orlistat were able to reduce their daily doses of other antidiabetic drugs, such as insulin, metformin and sulphonylureas.

'In controlled clinical trials, patients treated with Xenical experienced significant improvements in a number of cardiovascular risk factors, such as total cholesterol, LDL cholesterol, LDL/HDL ratio and blood pressure in addition to their improvements in glycaemic control and wieght loss,' said Roche's medical director, Dr Henry Solomon.