Weight-Loss Drug Xenical Approved In U.S. For Treatment Of Obesity

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The U.S. Food and Drug Administration (FDA) today (April 26) granted marketing approval of Hoffmann-La Roche Inc.'s Xenical® (orlistat).

The drug is the only prescription lipase inhibitor and acts by blocking the absorption of dietary fat by approximately 1/3. Xenical is indicated for obesity management including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet. Xenical is also indicated to reduce the risk for weight regain after prior weight loss.

When compared to diet alone, weight loss with Xenical has resulted in measurable improvements in certain obesity-related conditions, such as high blood pressure, high cholesterol and diabetes.

Unlike other anti-obesity agents that work in the brain to suppress appetite, Xenical through its fat-blocking mode of action works non-systemically in the gastrointestinal tract, not requiring entry into the bloodstream or brain. Xenical [pronounced: zen'-i-cal] will be available to patients by prescription in the coming weeks.

Xenical is recommended for use three times daily with meals that contain up to 30 percent fat, consistent with current U.S. dietary guidelines. Blocking 1/3 of fat from digestion means that a patient who ingests 60 grams of fat a day may absorb only 40 grams of fat. The other 20 grams will be excreted through the digestive tract.

Xenical is indicated for obese patients with an initial body mass index (BMI) of greater than or equal to 30 or greater than or equal to 27 in the presence of other risk factors, such as high blood pressure, high cholesterol and diabetes. Body mass index (BMI) is the most widely accepted measurement of obesity.

Xenical is contraindicated in patients with chronic malabsorption syndrome or cholestasis. Organic causes of obesity, such as hypothyroidism, should be excluded before prescribing Xenical.

"We now recognize that excess fat consumption is a contributor to health threats such as obesity and its related risk factors," said Louis J. Aronne, MD, Director of the Comprehensive Weight Loss Clinic, Cornell University Medical College, and a principal investigator in the Xenical clinical trials. "I believe that Xenical's unique mechanism of action and efficacy value will play a critical role in the medical management of patients with obesity- related risks."

"We believe that Xenical will provide significant benefit to millions of obese Americans," said Patrick J. Zenner, President and Chief Executive Officer of Hoffmann-La Roche Inc., the U.S. pharmaceuticals affiliate of Swiss-based Roche Holding Ltd. "Obesity is escalating at epidemic rates in this country. Recognizing that long-term weight loss success may depend on the integration of drug therapy with diet, exercise and lifestyle modification, Roche is committed to providing comprehensive support to all patients and health care providers. Upon the availability of Xenical, Roche will also debut a novel education and counseling initiative to ensure appropriate use of Xenical."

Xenical is currently available in 17 other countries (Argentina, Austria, Belgium, Brazil, Chile, Denmark, Finland, France, Germany, Italy, Mexico, The Netherlands, New Zealand, Spain, Switzerland, Venezuela and United Kingdom) and will soon be introduced in other worldwide markets. To date, more than 1,000,000 patients have been treated with Xenical in these countries.

Gastrointestinal symptoms are the most commonly observed side effects associated with the use of Xenical and are primarily a manifestation of its mechanism of action. These effects are generally mild and transient and may include oily spotting, flatulence with discharge, fecal urgency, fatty or oily stool, oily evacuation, increased defecation and fecal incontinence. Maintaining the recommended dietary regimen -- containing up to 30 percent of calories from fat -- may minimize the occurrence of these events.

Because Xenical partially blocks fat absorption, it has been shown to reduce the absorption of the fat-soluble vitamins A, D, E and K as well as beta-carotene. Therefore patients are advised to take a daily supplement that contains fat soluble vitamins and beta-carotene.