EC approves GSK's OTC orlistat product alli

26 January 2009

The European Commission has approved UK drug major GlaxoSmithKline's non-prescription drug alli (orlistat 60mg), the first switch of a  centrally-authorized weight loss medicine to over-the-counter status.  The approval means GSK can now introduce alli for adults with a Body  Mass Index of 28kg/m2 or more, in all 27 European Union member states.  Plans are underway to launch it in the coming months. The prescription  version of the drug is sold as Xenical by its developer Swiss drug major  Roche, which licensed the OTC rights to GSK. Clinical trials show that  alli, when used in conjunction with a reduced calorie, lower-fat diet,  can help people lose 50% more weight than by dieting alone. The agent is  a lipase inhibitor that prevents dietary fat from being absorbed. It has  helped millions of patients in the USA where it is already marketed.

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