Non Prescription Weight Loss Pill Gets European Go Ahead

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Main Category: Obesity / Weight Loss / Fitness
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 22 Jan 2009 - 1:00 PDT

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Drug company GlaxoSmithKline (GSK) has received the go ahead to market its non-prescription weight loss pill alli (orlistat) in Europe; the drug has already been on sale over the counter in the US for over year.

News came in yesterday, Wednesday 21 January, that the European Medicines Agency (EMEA) has granted license to GSK to market its non-prescription weight loss pill alli (orlistat 60mg) in all 27 member countries of the European Union, plus Norway. The drug is aimed at adults with a body mass index of 28 kg/m2 or more, that is those who are overweight or obese (BMI of 25 or more is classed as overweight).

GSK said it is planning to launch the drug over the next few months.

There is no news of the price, but in the US it costs about the equivalent of 1 Euro (about 1 British pound) a day. The drug is not intended to replace but to enhance the effect of dieting and exercise, said GSK.

In the US, alli has "successfully helped millions of users lose weight gradually and steadily, and adopt a healthy lifestyle," said Manfred Scheske, GSK's president of consumer healthcare in Europe. The product was launched in the US in June 2007, as the only non-prescribed Food and Drug Administration (FDA) approved weight loss aid.

In trials, people lost 50 per cent more weight when they used alli with a reduced calorie, lower fat diet than dieting alone; thus helping them lose an extra pound for every two pounds they would lose if they dieted but did not take the pill.

Alli (orlistat), a lipase inhibitor, works by stopping the fat we eat from being turned into body fat. It acts locally within the digestive system and thus very little of the active ingredient goes into the bloodstream, said GSK in a statement.

The drug has been on prescription for over 10 years and over 100 clinical studies have yielded information about its safety and efficacy, said the company.

In February 2007, GSK signed an agreement with Roche that allowed it to seek approval for the 60 mg version as Europe's first licensed non-prescription weight loss product. Roche market the 120 mg prescription version as Xenical (orlistat) capsules.

An obesity expert from Germany's Cardio-Metabolic Institute, professor Stephan Jacob said that studies have shown every year people spend millions of Euros on fad diets, so-called "miracle pills" and potentially unsafe weight loss supplements, many of which are scientifically unproven.

"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," said Jacob, explaining that for many people losing weight spur them to do other things that improve their health and self esteem.

GSK said that alli is for people with a BMI of 28 or higher for use in conjunction with a reduced calorie, lower fat diet. The advised dose is one 60 mg capsule three times a day, taken with meals that have the recommended amount of fat.

Click here for EMEA.

Sources: GSK.

Written by: Catharine Paddock, PhD
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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