WC500058424.pdfVIP

1/14 ?EMEA 2005 SCIENTIFIC DISCUSSION This module reflects the initial scientific discussion for the approval of Xenical. This scientific discussion has been updated until 1 November 2003. For information on changes after this date please refer to module 8B. 1. Introduction Obesity is a disease characterised by an excess body fat. It is often measured by calculation of the body mass index (BMI), i.e. the body weight in kg divided by body surface area in m2. Individuals may be regarded as obese with a BMI 25-27 kg/m2 (depending on age). A number of concomitant pathological processes and diseases are associated with obesity including coronary heart disease, hypertension, stroke, non-insulin dependent diabetes mellitus and certain forms of cancer. Besides changes in diet, behaviour and physical activities, obesity may be treated by surgery or pharmacological therapy. All currently available medicinal products for obesity treatment are appetite suppressants (amphetamine-like products) that act via the central nervous system (CNS). However, they may not be prescribed during longer periods than 3 months, due to the potential risk of abuse. Thus, there is a need for medicinal products that can be used in chronic treatment together with dietary and behavioural modifications. Orlistat belongs to a new class of pharmacological agents. It inhibits the action of gastrointestinal lipases and thereby impairs the metabolism of lipids in the intestinal lumen leading to a prevention of lipid absorption. Xenical is indicated in conjunction with a mildly hypocaloric diet for the treatment of obese patients with a body mass index (BMI) greater or equal to 30 kg/m2, or overweight patients (BMI 28 kg/m2) with associated risk factors. The treatment should only be started if diet alone has previously produced a weight loss of at least 2.5 kg over a period of 4 consecutive weeks. Treatment with orlistat should be discontinued after 12 weeks if patien