Media Release
Basel, 28 June 2005 1
Xenical
gains European approval for use in young people
Only weight loss
medication whose benefits have been studied in adolescents
Roche announced
today that its leading weight loss medicine Xenical (orlistat) has received European approval to include
clinical, safety and efficacy data in the label on the use in obese adolescents aged 12 years or over.
The label change has been approved following the results of a major study that shows Xenical to be highly
effective in helping obese young people to lose weight. As a result of this change, physicians may now
consider Xenical as an effective option in the management of obesity in adolescents.
In
Europe in the last few years there has been a significant increase in obesity in children and adolescents,
with as many as one in four affected in some regions. Obese children tend to become obese adults, and
they carry a high risk of acute and chronic diseases, leading to reduced life expectancy. Treatment
and prevention of childhood obesity has been identified as a healthcare priority in Europe.
“This
is a further example of Roche's continuing commitment to tackling the growing epidemic of obesity. By
studying the use of Xenical in obese adolescents aged 12 and over, we have now shown that the drug can
benefit young people as much as adults. Xenical is now the only weight loss treatment in the US and
EU that provides guidance from clinical trials in its label on use in this population,” said William
M. Burns, CEO Roche Pharma.
The label change is based on data from a
large study (recently published in JAMA
Study
results were consistent with those seen in adults and showed at the end of treatment:
•
Adolescents treated with Xenical had a significantly reduced BMI (decrease of 0.55 kg/m2 compared to
an increase of 0.31 kg/m2 in the placebo group).
• Almost twice as many adolescents treated
with Xenical reduced by ≥5% their BMI (26.5% vs 15.7%) and their body weight (19% vs 11.7%)
•
Adolescents treated with Xenical had a greater decrease in body fat (2.4kg vs 0.4kg)
•
Waist circumference decreased significantly in Xenical recipients, but increased in placebo recipients
(–1.33 cm vs +0.12 cm).
• Adolescents who responded to treatment (≥5% weight loss at
12 weeks) had a reduction in body weight of 7.6 kg and a BMI decrease of 3.7 kg/m2.
•
Treatment was well tolerated, with adverse events generally similar to those observed in adults.
These
data, from the largest and longest study of a weight loss medication in adolescents, add to the extensive
evidence base including safety, and clinical experience gained with Xenical since it was first marketed
in 1998.
“Access to pharmacotherapy such as orlistat to complement diet
and exercise will be important for physicians and patients trying to combat the growing trend of adolescent
obesity. It means that the medical profession will have a new weapon to help adolescents lose weight,
and stop them progressing to become overweight adults with the associated health complications” commented
lead investigator Professor Prof. Jean-Pierre Chanoine, Endocrinology and Diabetes Unit, British Columbia
Children's Hospital, Vancouver, Canada.
About Xenical
Xenical
is the number one prescription weight loss medication, approved for use in adults in over 50 countries
worldwide. Xenical has a unique mode of action, it works locally in the gut to prevent dietary fat absorption
by around 30 percent and effectively promotes weight loss. It is the most extensively studied pharmacological
weight management treatment to date, with over 30,000 overweight or obese patients participating in
clinical trials with Xenical, including the 4 year landmark XENDOS study. It is an effective therapy
that not only helps patients lose weight, but also helps them maintain their weight loss. Xenical was
approved in December 2003 for use in adolescents 12 years and above in the US.
About
Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading
research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of
innovative products and services for the early detection, prevention, diagnosis and treatment of disease,
the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche
is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and
a market leader in virology. In 2004 sales by the Pharmaceuticals Division totalled 21.7 billion Swiss
francs, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly
65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners,
including majority ownership interests in Genentech and Chugai.
All trademarks used or mentioned in this release are legally protected.
Additional information
- Roche Health Kiosk, Overweight
- Managing your weight
Reference:
1.
Chanoine J-P, Hampl S, Jensen C, Boldrin M, Hauptman, J. Effect of orlistat on weight and body composition
in obese adolescents: A randomized controlled trial. JAMA. 2005; 293:2873 - 2883