GlaxoSmithKline (GSK) announced its marketing application for non-prescription Orlistat 60mg for weight loss has been accepted for review by the European Agency for the Evaluation of Medicinal Products (EMEA).
Orlistat 60 mg was approved for non-prescription sale in the US by the FDA in February 2007 for use by overweight adults in conjunction with a reduced-calorie; low fat diet and went on sale there in June 2007 under the brand name Alli. Alli is the only FDA-approved weight-loss product available to consumers without a prescription, and it is the first clinically proven over-the-counter product to be combined with a comprehensive support programme, the company stated in a press release.
"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 Europe and 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," said, John Clarke, president, GSK Consumer Healthcare
"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 Europe as 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 per cent more weight than with diet alone," he added
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.
Orlistat is the most comprehensively studied weight loss medication to date. Its safety and efficacy are well documented and have been established through data from more than 100 clinical studies involving more than 30,000 patients, the company said.
One of these studies or Xenical, was the four-year landmark XENDOS trial conducted by Roche, its inventor and manufacturer. In this study alone, over 3,000 people were followed for four years while taking Orlistat, and it is the longest completed study conducted to date for a weight-loss medicine. In all, since the launch of the 120 mg dose of Orlistat as the prescription drug Xenical in 1999, there have been more than 28 million patient treatments with Orlistat in more that 145 countries worldwide.
GlaxoSmithKline completed an agreement with Roche in February 2007 that enables the company to seek regulatory approval for the first non-prescription weight loss medicine in countries outside of the US excluding Japan.