GlaxoSmithKline (GSK) has received a non-prescription licence for alli (orlistat 60mg); the first time the European Commission has approved a non-prescription product for weight loss. The centrally approved marketing authorisation means GSK can introduce alli for adults with a BMI of 28 kg/m2 or more, in all 27 EU member countries.
Manfred Scheske, President GSK Consumer Healthcare Europe said, "alli offers adults a real opportunity for losing weight. alli has been well received by millions of people in the US and we are very excited about the number of people it could help across Europe achieve their goal to lose weight."
Clinical trials show that alli, when used in conjunction with a reduced calorie, lower-fat diet, can help people lose 50 per cent more weight than by dieting alone.(1) So for every two kilos (pounds) lost by dieting alone, alli could help them lose one more. It works by stopping some of the fat you eat being absorbed into the body and turning into extra kilos (pounds).(2)
alli is a new category within weight loss management which is supported by a multi-million pound investment in pharmacy training, consumer marketing and a behavioural support programme in countries throughout Europe. It will be distributed exclusively through pharmacies.
Users can benefit from the online alli programme, which provides tools and support to help them follow a sensible diet and become more active, encouraging sustainable weight loss.
alli is a registered trade mark of the GlaxoSmithKline group of companies.
About alli
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A summary of product characteristics is available at www.emea.europa.eu
The active ingredient in alli is orlistat 60 mg
Orlistat 60 mg acts locally within the digestive system to prevent fat absorption, so there is minimal absorption of the active ingredient in the bloodstream(2)
Orlistat 120 mg has been available as a prescription treatment for 10 years
The safety and efficacy profile of orlistat is well documented and has been established through data from more than 100 clinical studies3
GlaxoSmithKline completed an agreement with Roche (who market prescription orlistat 120 mg) in February 2007 that allows the company to seek regulatory approval for orlistat
60 mg as the first licensed non-prescription weight loss product in Europe
The centrally approved marketing authorisation covers all 27 EU member countries, plus Norway
alli (orlistat 60 mg) was launched in the US in June 2007 as the only Food and Drug Administration (FDA) approved weight loss aid available without prescription
1. alliSummary of Product Characteristics (SPC)
2. Anderson J. Orlistat for the management of overweight individuals and obesity: a review of potential for the 60-mg, over-the-counter dosage. Expert Opin Pharmacother. 2007;8 (11):1733-1742.