Roche, GlaxoSmithKline get FDA committee support for over-the-counter orlistat for weight loss

New York, Jan. 23 - Roche and GlaxoSmithKline said the Food and Drug Administration's nonprescription drugs and endocrinologic and metabolic drugs advisory committee recommended that orlistat 60 mg capsules be approved for over-the-counter use in the United States to promote weight loss in overweight adults as part of a reduced calorie, low-fat diet.

If approved by the FDA, orlistate will be the only FDA-approved weight loss drug available over the counter.

Under an agreement with Roche, GlaxoSmithKline Consumer Healthcare proposes to market the drug under the name Alli.

GlaxoSmithKline Consumer Healthcare currently promotes prescription Xenical (orlistat 120mg) in the United States.

"We are encouraged by the committee's recommendation for approval of what would be the only FDA-approved safe and effective OTC weight-loss aid for overweight adults," said George Quesnelle, president of GlaxoSmithKline Consumer Healthcare North America. "We look forward to working with the FDA to gain final approval."

Xenical will remain available by prescription for obesity management including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet and to reduce the risk for weight regain after prior weight loss in patients with an initial body mass index greater than or equal to 30 kg/m or greater than or equal to 27 kg/m in the presence of other risk factors such as hypertension, diabetes or dyslipidemia. Xenical will continue to be marketed by Roche in the rest of the world.

Orlistat is a weight-loss medication that works locally in the gut by inhibiting the absorption of dietary fat and does not act centrally.

Roche is a Basel, Switzerland, healthcare company. GlaxoSmithKline is a London-based healthcare company.

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