GlaxoSmithKline’s consumer health arm is looking to get the green light to sell the anti-obesity agent orlistat as an over-the-counter treatment in Europe.
The firm says that its marketing application for non-prescription orlistat 60mg for weight loss has been accepted for review by the European Medicines Agency and is hopeful the product, which is a lower-dose version of the prescription drug Xenical marketed by Roche, will share the same success it has enjoyed across the Atlantic.
In the USA, the medicine, known as Alli, was approved in February this year for use by overweight adults in conjunction with a reduced-calorie, low-fat diet and went on sale there in June. By the end of the second quarter, Alli, the only Food And Drug Administration-approved weight-loss product available to consumers without a prescription, had already brought in £76 million in sales.
John Clarke, president of GSK Consumer Healthcare said the bid to get European approval is “a significant milestone and an important opportunity” for the firm. He added that obesity is “a rapidly increasing problem and a significant burden for healthcare systems in Europe and elsewhere” and “leveraging our considerable expertise in OTC switches” can help tackle this problem.
No magic pill
Mr Clarke noted that so far, Alli is performing well in the USA and if the latest 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 USA.” He concluded by saying that “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”.
GSK acquired the rights from Roche to an OTC version of Xenical in 2004 and another deal was signed in February this year to cover the rest of the world. Analysts have forecast that peak sales of Alli could reach £500 million.