John Clarke, President GSK Consumer Healthcare said: "This is a significant milestone and an important opportunity for GSK. Obesity is a rapidly increasing problem and a significant burden for healthcare systems in Europeand elsewhere. Leveraging our considerable expertise in OTC switches, we hope to offer consumers a new, clinically-proven option which can help to tackle this problem.
So far, alli is performing well in the US and, if our application is successful, we will commit to rolling out a similar responsible marketing campaign with the same level of support for consumers in Europeas we have done in the US. We want to see people achieving gradual, sustained weight loss by using alli in tandem with a healthy eating, low-fat diet and increased exercise. We've said all along that this is no magic pill. If people are looking for a quick fix, this is not it but it is a powerful motivator, helping people lose up to 50% more weight than with diet alone*."
If the regulatory process is successful, GSK would be granted a licence to market non-prescription orlistat 60mg in all 27 EU member countries, although initial launch markets have not been confirmed.
*- Anderson JW, Schwartz SM, Hauptman J et al. Low-dose orlistat effects on body weight of mildly to moderately overweight individuals: a 16 week, double-blind, placebo-controlled trial. Ann Pharmacother 2006; 40: 1717-23
- Study BM14149 and study NM14161. GSK data on file.
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. For more information, please visit www.gsk.com.