GSK Receives Positive Opinion For Alli(R) (orlistat 60 Mg) As A Non-prescription Weight Loss Aid In Europe

Main Category: Obesity / Weight Loss / Fitness
Also Included In: Regulatory Affairs / Drug Approvals;  Pharmacy / Pharmacist
Article Date: 24 Oct 2008 - 2:00 PDT

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Thursday 23 October 2008, London GlaxoSmithKline (GSK) announced today that alli (orlistat 60 mg) has received a positive opinion as a non-prescription product from the Committee for Medicinal Products for Human Use (CHMP). This means the product will now be proposed for final approval by the European Commission and marketing authorisation could be granted in the coming months. On licence grant, orlistat 60 mg would be the first licensed weight loss aid available without prescription throughout Europe. The product will be indicated for adults who are 18 and over with a BMI of 28 kg/m2 or over.

Manfred Scheske, President GSK Consumer Healthcare Europe said: "Receiving positive opinion for orlistat 60 mg is a significant milestone for the product. With around half of the adult population in Europe overweight, of whom up to a third are obese, we are thrilled that the CHMP has proposed approval. alli has been available in the US for a year and been tried by millions of people so far, helping sensible dieters boost their efforts to lose weight and achieve sustainable weight loss."

Clinical trials show that orlistat 60 mg, in conjunction with a reduced calorie, lower-fat diet, can help people lose 50 per cent more weight than dieting alone.1 So if someone were to lose 2 kilos (4 pounds) by dieting alone, orlistat 60 mg could help them lose 3 kilos (6 pounds). It works by stopping about 25 per cent of the fat from the food you eat 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 making lifestyle changes to help boost weight loss.

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. In the US, users are supported by a comprehensive online programme to help weight loss efforts and address long-term healthy eating patterns. Orlistat 60 mg acts locally within the gastrointestinal tract to block fat absorption, so there is minimal absorption of the active ingredient into the bloodstream.2

If the marketing authorisation is granted, GSK would receive a licence to market orlistat 60 mg in all 27 EU member countries.

alli is a registered trade mark of the GlaxoSmithKline group of companies.

- A summary of the CHMP opinion is available on the EMEA website: http://www.emea.europa.eu

- If the licence is granted by the EU Commission, alli will be indicated for weight loss in adults who are overweight with a BMI of 28 kg/m2 or over, and should be taken in conjunction with a reduced calorie, lower-fat diet.

About alli

- The active ingredient in alli is orlistat 60 mg.
- 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 studies.3
- GlaxoSmithKline completed an agreement with Roche (who market prescription orlistat 120 mg) in February 2007 that enables the company to seek regulatory approval for orlistat 60 mg as the first licensed non-prescription weight loss product in Europe.

About GSK

GlaxoSmithKline (GSK), 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. GSK recently launched alli, the first FDA approved OTC product for weight loss in the US, and is committed to tackling the public health burden of obesity globally.

For company information, please visit http://www.gsk.com.

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.

Source
Emily Brooks E
http://www.virgohealth.com