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FDA Joint Advisory Committee Recommends Approval of Orlistat 60 mg Capsules for Over-the-Counter Use

Orlistat would be the only FDA-approved weight-loss treatment available over-the-counter

PITTSBURGH, PA -- January 24, 2006 -- GlaxoSmithKline Consumer Healthcare announced that the U.S. Food and Drug Administration's (FDA) joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee voted 11 to 3 to recommend approval of orlistat 60 mg capsules for over-the-counter (OTC) use in the United States.

OTC orlistat, which GSK proposes to market under the brand name Alli™ (pronounced AL-eye), would be the only FDA-approved weight loss medication available over-the-counter. Alli would be indicated for use by overweight adults along with a reduced calorie, low-fat diet.

"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, GlaxoSmithKline Consumer Healthcare North America. "We look forward to working with the FDA to gain final approval."

"We are excited by the potential opportunity to provide consumers with an FDA-approved over-the-counter option that promotes gradual yet meaningful weight loss. Alli will be more than a pill; it will be a program that will help people lose weight, adopt a healthy eating plan and make other lifestyle changes," added Quesnelle.

Unique among weight loss medications, orlistat is non-systemic. It does not affect the central nervous system, and has no effect on the heart or the brain.

Orlistat is a weight-loss medication that is taken with meals to inhibit the absorption of dietary fat. Orlistat should be used in conjunction with a reduced calorie diet that contains no more than 30% of calories from fat. Following such a diet maximizes weight loss and minimizes unwanted gastrointestinal treatment effects. Help and advice on adopting a healthy eating plan will be provided in the Alli program.

The safety and efficacy of orlistat, which has been marketed as a prescription drug in the U.S. since 1999, is supported by more than 100 clinical studies conducted in more than 30 countries, including the four-year landmark XENDOS trial, the longest study ever of a weight loss medicine. More than 22 million people in 145 countries have used orlistat.

Xenical® (orlistat 120 mg capsules) will remain available by prescription for obesity management and for those who should be treated under the care of a physician. Xenical is manufactured by Roche and co-promoted in the U.S. by GlaxoSmithKline Consumer Healthcare.

Overweight and Obesity
Currently, 65% (or approximately 130 million) of U.S. adults are overweight or obese, according to the National Institutes of Health. Research suggests that overweight individuals appear to be on the pathway to obesity.[1],[2] Overweight and obesity are associated with an increased risk of developing health problems such as hypertension, type 2 diabetes and heart disease.[3] Factors that can contribute to overweight include an abundance of high-calorie foods, low levels of physical activity, behavior, environment, and genetics.[4] Multiple studies have shown that a modest reduction in weight improves health outcomes significantly in overweight or obese patients.[5]


REFERENCES:
1. Flegal KM, Carroll MD, Ogden CL, Johnson CL. Prevalence and trends in obesity among US adults, 1999-2000. JAMA 2002;288:1723-1727.
2. McTigue KM, Garrett JM, Popkin BM. The natural history of the development of obesity in a cohort of young US adults between 1981-1998. Ann Intern Med 2002;136:857-864.
3. Centers for Disease Control and Prevention: "Overweight and Obesity." http://www.cdc.gov/nccdphp/dnpa/obesity/. Accessed 12/22/05.
4. Centers for Disease Control and Prevention. "Overweight and Obesity: Contributing Factors." http://www.cdc.gov/nccdphp/dnpa/obesity/contributing_factors.htm. Accessed 12/22/05.
5. Hauptman J, Lucas C, Baldrin MN, Collins H, Segal K. "Orlistat in the long-term treatment of obesity in primary care settings." Archives of Family Medicine 9:160-167.


SOURCE: GlaxoSmithKline Consumer Healthcare

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