Alli Diet Pill approval May Benefit from Diet Drug Acomplia Safety concern

GlaxoSmithKline receives European Medicines Agency approval to market alli® (orlistat 60mg). A decision made by the European Medicines Agency on 21 Jan 2009 opens access to a treatment that could help people who are overweight and obese. GlaxoSmithKline (GSK) has got a non-prescription license for alli (orlistat 60mg). It is the first time when European Commission has approved a non-prescription product for weight loss. The centrally approved marketing authorisation means GSK can now introduce alli for adults with a BMI of 28 kg/m2 or more, in all 27 EU member countries. Campaigns are on track to launch alli diet pill in the coming months. Analysts estimate the launch of Alli will be one of the biggest ever non-prescription product for weight loss.

The suspension of Acomplia sales on 23 Oct 2008 in Europe struck a knockout blow to the most promising drug to tackle the modern health scourge since fen-phen, the combination treatment prescribed 6 million times before it was recalled for deadly side effects more than a decade ago. Acomplia diet pill failed to win the backing of a U.S. advisory panel last year. The London-based European Medicines Agency, which approved Acomplia in 2006, recommended the suspension of sales because the drug's risk of psychiatric side effects outweighed any benefits.

Manfred Scheske, President GSK Consumer Healthcare Europe said: “alli, in the US, has successfully helped millions of users lose weight gradually and steadily, and adopt a healthy lifestyle. We are very excited about the opportunity to create similar success in Europe and we will be launching alli in pharmacies throughout Europe soon.”

The active ingredient in alli is orlistat 60 mg. Orlistat 60 mg acts locally within the digestive system to prevent fat absorption, so there is minimal absorption of the active ingredient in the bloodstream. Orlistat 120 mg has been available as a prescription treatment for 10 years. The safety and efficacy profile of orlistat is well documented and has been established through data from more than 100 clinical studies. GlaxoSmithKline completed an agreement with Roche (who market prescription orlistat 120 mg) in February 2007 that allows the company to seek regulatory approval for orlistat 60 mg as the first licensed non-prescription weight loss product in Europe. The centrally approved marketing authorisation covers all 27 EU member countries, plus Norway. Alli (orlistat 60 mg) was launched in the US in June 2007 as the only Food and Drug Administration (FDA) approved weight loss aid available without prescription.

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