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FDA Approves Orlistat for Use in Teenagers

NUTLEY, N.J., Dec. 15 /PRNewswire/ -- Roche today announced that the U.S. Food and Drug Administration has approved labeling for use of the prescription weight-loss medication Xenical(R) (orlistat) in the management of obese adolescents ages 12 to 16 years. This is the first approval of its kind for a prescription weight-loss treatment.

"This is very good news for adolescents struggling with overweight and obesity," said Marc S. Jacobson, M.D., attending physician and director of the Center for Atherosclerosis Prevention in the Division of Adolescent Medicine at Schneider Children's Hospital of North Shore-Long Island Jewish Health System. "Obesity is an epidemic, with the number of obese adolescents doubling over the last 20 years. Physicians and parents of overweight and obese adolescents now have a safe and effective treatment option available that will help manage their child's weight."

Obesity Puts Adolescents At Risk
Overweight and obesity has reached epidemic proportions in the United States. Currently, about 15% of adolescents in the U.S. are obese, and 30% are overweight. Poor dietary habits and physical inactivity have been clearly identified as contributors to this growing health problem. Adolescents who are obese are at greater risk of being obese as adults and of developing serious health problems, including type 2 diabetes and heart disease, and have an increased risk of mortality. According to the National Diabetes Education Program (NDEP), some clinics are now reporting that one-third to one-half of all new cases of childhood diabetes are type 2 and that the overall number of new cases is increasing.

"If a parent is concerned that their child may be overweight, it's important to talk with their physician," said Dr. Jacobson. "Combining diet, exercise and changes in lifestyle habits with medication can help seriously overweight adolescents manage their weight and reduce their risk of serious health problems."

Clinical Studies Results
The safety and efficacy of Xenical in obese adolescents was assessed in a randomized, 54 week double-blind, placebo-controlled study that involved 539 patients aged 12 to 16 (120 mg of Xenical or matching placebo was administered three times a day with meals. This dose is consistent with the currently approved dose of Xenical for adults). Of this group, 357 were treated with Xenical and a reduced-calorie diet containing no more than 30% of calories from fat compared with 182 patients treated with placebo and diet. The average age of participants was 13 and-a-half years with an average weight of approximately 210 lbs., putting them in the 99th percentile for their age. Body mass index (BMI) was the primary efficacy parameter because it takes into account changes in height and body weight, which occur in growing children.

Study results showed that at the end of treatment:

* Patients treated with Xenical plus diet had a significantly reduced BMI compared with patients receiving placebo plus diet

* A greater than or equal to 5% reduction in BMI was achieved in 27% of patients receiving Xenical plus diet compared with 16% of patients receiving placebo plus diet

* Tolerability was good and reported adverse events were generally similar to those seen in adults treated with Xenical such as fatty/oily stool, oily spotting and oily evacuation consistent with the drug's mechanism of action

* The reduction in BMI was associated with greater loss of body fat in the Xenical plus diet-treated patients compared with the placebo plus diet patients (5.5 lbs. vs. 1.3 lbs.), while both groups experienced a similar increase in fat free mass and bone mineral content (as expected with normal growth).

A second study showed that the balance of calcium, magnesium, phosphorus, zinc or copper was not decreased and was similar in those receiving Xenical compared with those receiving placebo. The iron balance was decreased in both the Xenical treated patients and the placebo patients.

About Xenical
Xenical is the only available weight-loss medication that works locally in the gut to prevent dietary fat absorption by around 30% to effectively promote weight loss. It is an effective therapy that not only helps patients lose weight, but also helps them maintain their weight loss. Xenical is well tolerated and unlike appetite suppressants which act on the central nervous system. Since it was first marketed in 1998, there have been more than 16.7 million patient treatments with Xenical worldwide. Xenical is approved for weight management in over 140 countries around the world.

The long-term effects of Xenical on morbidity and mortality associated with obesity have not been established. Because Xenical prevents about one-third of the fat in the food consumed from being absorbed, patients may experience gas with oily discharge, increased bowel movements, an urgent need to have them and an inability to control them, particularly after meals containing more fat than recommended. Xenical should not be taken if patients are pregnant, nursing, have food absorption problems or reduced bile flow. If taking cyclosporine, patients should speak to their doctors before taking Xenical. Xenical reduces the absorption of some vitamins. Therefore, a daily multivitamin is strongly recommended. For more information about Xenical visit the web site at https://www.cheplapharm.com/.

Source: Roche

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