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Home Industry News GSK looks to Europe for marketing license

GSK looks to Europe for marketing license

4th October 2007

GlaxoSmithKline (ASK) has announced that it is has applied for a licence to market its orlistat 60mg weight loss product in Europe.

The European Agency for the Evaluation of Medicinal Products (EMEA) has accepted a review of the non-prescription drug and if successful GSK would be granted a licence to market non-prescription orlistat 60mg in all 27 EU member countries.

John Clarke, president of GSK consumer healthcare, stated the importance of the application for both the company and for the healthcare systems of Europe.

“This is a significant milestone and an important opportunity for GSK. Obesity is a rapidly increasing problem and a significant burden for healthcare systems in Europe and elsewhere.”

Orlistat 60mg was granted approval for non-prescription sale in the US in February 2007 and hit the shelves as Alli, intended to be used by overweight adults in conjunction with a reduced-calorie, low-fat diet.

Alli is currently the only non-prescription weight loss product to be approved by the US Food and Drug Administration.

Earlier this year, GSK announced that it had received approval from the European commission for Atriance (nelarabine solution for infusion) as a treatment for patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL).

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