EMEA Recommends Rx-to-OTC Switch for Orlistat

London (Oct. 23)-The European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) recommended that the status of GlaxoSmithKline’s (GSK, London) anti-obesity drug “Alli” (orlistat) be switched from prescription-only to nonprescription. This change marks the first time that EMEA has recommended that the status for supply of a centrally authorized medicine in the European Union be switched from prescription-only to nonprescription, according to EMEA.

EMEA recommended the switch as part of an extension of the marketing authorization in response to an application by the marketing-authorization holder for a lower-dose capsule (60 mg) with a new classification as a nonprescription medicine. Alli (60 mg) is used in conjunction with dieting for treating overweight patients who have a body mass index of 28 or above.

“This is the first time a nonprescription product has been centrally reviewed and given a positive opinion by the CHMP,” said John Clarke, president of GSK Consumer Healthcare, in a company press release. “This is a real testimony to the strength and regulatory expertise that GSK has within the consumer-healthcare arena.”

Following review of the required data for Alli (60 mg), the CHMP concluded that the switch could be recommended because of the following:
• The 60-mg dose was effective in helping patients to lose weight when taken in conjunction with dieting
• Its side effects were milder than those with the existing 120-mg dose
• The package leaflet and the label will enable patients to use the medicine correctly and appropriately.

The CHMP’s recommendation will be sent to the European Commission for the adoption of the decision.

Pending approval, which could be granted by the end of 2008, GSK says that it anticipates launching the product in 2009 as the first licensed weight-loss treatment available without a prescription.

For further information on EMEA’s guideline on changing the classification for the supply of a medicinal product for human use, click

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For more information on Alli, see the European public assessment report.