GSK France welcomes alli launch OK from EC

GSK France, the local unit of UK-headquartered pharmaceutical giant GlaxoSmithKline, has welcomed the first Europe-wide approval of an  over-the-counter drug with the launch of anti-obesity agent alli  (orlistat), a half-dose formulation of the 120mg prescription-only  Xenical, which was developed by Swiss drug major Roche (Marketletters  passim). GSK has marketing rights of the 60mg product.

Martine Frey, a spokeswoman for GSK France, told the Marketletter that  clinical trial data indicates that the average weight loss for alli  users is 5% with 16% achieving a loss of 10% or more from their  pre-treatment weight. The French drug safety watchdog, the AFSSAPS, is  concerned over the OTC move, briefing local media outlets of concerns  that non-obese people would be tempted to abuse the drug (Marketletter  April 20). The OTC switch means that previous risk-management measures  aimed at physicians will need to be amended to account for the increased  role of pharmacists, including training and monitoring.