This press release is intended for business journalists and analysts/investors. Please note that this release may not have been issued in every market in which GSK operates.
GSK receives positive CHMP opinion for new non-prescription weight loss treatment – alli® – to help in the fight against obesity across Europe
Issued: Thursday 23 October 2008, London UK
GlaxoSmithKline (GSK) today announced that alli
® (orlistat 60mg) has received a positive opinion from the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) as a non-prescription product. As a result, approval of alli (orlistat 60mg)could be granted by the end of the year across all 27 EU member countries with an anticipated launch in 2009 as the first licensed weight loss treatment available without a prescription. The product would be indicated for adults who are overweight and have a body mass index (BMI) of 28 or more.
John Clarke, President GSK Consumer Healthcare, commented, “This is a significant milestone for GSK’s Consumer Healthcare business and, following full approval, will provide us with an unprecedented opportunity to help people in Europe who are overweight and obese, which is a significant and growing problem affecting around half of all adults. With the increasing importance of self-medication, clinically proven products that are available for consumers to purchase provide real solutions to help manage long-term health issues, whilst also alleviating pressure on healthcare budgets.”
It is anticipated that the European launch of orlistat 60mgwill be a key new growth driver for GSK Consumer Healthcare. The availability of the product in Europe will build on the strong sales momentum seen in the USA following its successful launch in 2007.
Proven clinical benefit
Orlistat 60mg has been proven to help people lose 50 per cent more weight than dieting alone.1 It works by stopping about 25 per cent of the fat from food eaten being absorbed from the digestive system into the body and turning into extra kilos/pounds.2 It provides an extra motivation to stick to a reduced calorie, lower-fat diet and to make lifestyle changes to help boost weight loss.
John Clarke added, “This is the first time a non-prescription product has been centrally reviewed and given a positive opinion by the CHMP. This is a real testimony to the strength and regulatory expertise that GSK has within the consumer healthcare arena.”
About alli
- A summary of the CHMP opinion is available on the EMEA website: www.emea.europa.eu
- Upon full licence,orlistat 60mg will be indicated for weight loss in adults who are overweight with a BMI of 28 kg/m2 or more, and should be taken in conjunction with a reduced calorie, lower-fat diet.
- The safety and efficacy profile of orlistat is well documented and has been established through data from more than 100 clinical studies.3
- The most common side-effects associated with orlistat 60mg are diet-related treatment effects, such as wind (flatulence), sudden bowel motions and oily stools, which are largely manageable.
- Orlistat 120mg capsules have been available as a prescription treatment for 10 years.
- GlaxoSmithKline completed an agreement with Roche (who market prescription orlistat 120mg) in February 2007 that enabled the company to seek regulatory approval for orlistat 60mg as the first licensed non-prescription weight loss product in Europe.
GlaxoSmithKline - one of the world’s leading research-based pharmaceutical and healthcare companies, is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
The consumer healthcare business brings an added dynamic dimension to our company, with well known brands like Panadol, NiQuitin, Sensodyne and Aquafresh among others but, as with all our products, the driving force behind our consumer healthcare business is science. With four dedicated consumer healthcare R&D centres and consumer healthcare regulatory affairs, the business takes scientific innovation as seriously as marketing excellence and offers leading-edge capability in both.
alli
is a registered trade mark of the GlaxoSmithKline group of companies.
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Enquiries:
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UK Media enquiries:
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Philip Thomson
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Claire Brough
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Alice Hunt
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Gwenan White
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US Media enquiries:
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Nancy Pekarek
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Mary Anne Rhyne
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Sarah Alspach
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European Analyst/Investor enquiries:
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David Mawdsley
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(020) 8047 5564
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Sally Ferguson
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(020) 8047 5543
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Gary Davies
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(020) 8047 5503
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US Analyst/ Investor enquiries:
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Tom Curry
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UK Consumer Health:
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Linda Wallace
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07920 567789
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Claire Dixon
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07717 801391
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References
1. GSK data on file.
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.
3. Jacob S, Togerson J. Orlistat Treatment Beneficial in Both Primary Care and Tertiary Settings. Obesity Reviews. 2005; 6(s1):166.
