GlaxoSmithKline has received European Commission approval to market Alli, making it the first over-the-counter drug to be approved for people who are overweight and obese.

The decision means that GSK will start launching Alli (orlistat 60mg) across the continent in the coming months. The drug will be available to adults with a body mass index (BMI) of 28 or more, who are on a reduced calorie, lower-fat diet.

Alli is a lower-dose version of the prescription drug Xenical marketed by Roche, which has had a fair degree of success in the USA where it was launched in February 2007. Manfred Scheske, president of GSK Consumer Healthcare Europe said the drug has “successfully helped millions of users lose weight gradually and steadily, and adopt a healthy lifestyle” in the USA. “We are very excited about the opportunity to create similar success in Europe,” he added.

GSK also cited Stephan Jacob from the Cardio-Metabolic Institute, Germany, who said research has shown that consumers are spending millions of euros each year “on fad diets, unproven ‘miracle pills’ and potentially unsafe weight-loss supplements, often without any scientific evidence to back them up”. By making a licensed non-prescription product available, “consumers will have the option of a proven therapy which can support them with their struggle against weight loss”, he added.

Pricewise, GSK said that Alli will cost patients in the UK about the same as that paid by people in the USA - currently $2 (£1.44) per day.