GlaxoSmithKline (GSK) has received a positive opinion from the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) for Alli (Orlistat 60mg) 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.
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. 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 had 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.