KNOLL RECEIVES POSITIVE DECISION FROM EUROPEAN COMMISSION FOR ITS ANTI-OBESITY DRUG REDUCTIL
Abbott Laboratories' unit Knoll announced today that the European Commission issued a positive decision for Reductil (active ingredient: sibutramine) for treatment of obesity. This decision confirms the recommendation made by the Committee for Proprietary Medicinal Products (CPMP) in November 2000. The approval allows for national marketing authorizations in European Union member states.
"Obesity is a serious medical condition that often necessitates medical intervention," said Dr. Eddie Chong, Global Team Leader for Obesity Clinical Development at Knoll. "Reductil will provide physicians in Europe with an important and effective weight control product for the management of this disease."
Scientific evidence has shown that obesity seriously puts health at risk. It is associated with a higher incidence of severe diseases such as diabetes or coronary artery disease. Clinical trials demonstrated that weight loss induced by Reductil is accompanied by beneficial changes in serum lipids and glycaemic control.
Knoll expects that Reductil will be available throughout the European Union by mid-2001. The product has been introduced in nearly 40 countries around the world, with more than three million prescriptions written since its introduction.
Reductil is the first of a new generation of prescription weight management products that gives long-term control of weight to patients and their physicians. Eating habits are controlled in the brain. By acting centrally at the source of the problem, Reductil helps the overweight lose weight and keep it off. By making people feel satisfied with smaller portions Reductil helps to control food intake.
Reductil is indicated as adjunctive therapy within a weight management programme for obese patients, or for overweight patients if obesity-related risk factors such as type 2 diabetes or dyslipidaemia are present. Reductil is for use by patients who have not adequately responded to weight-reducing regimens and it should be used under the care of a physician.
In clinical trials, the most commonly reported adverse events were loss of appetite, constipation, dry mouth, and insomnia. A few patients also experienced increases in blood pressure. Most side effects occurred at the start of treatment and the severity and frequency diminished overtime.
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