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Over the last 20 years, the global prevalence of obesity in children and adolescents has doubled from 1 in 10 to 1 in 5,2,3 and now more than 124 million children and adolescents live with obesity globally.4 Adolescents with obesity are more likely to develop weight-related complications, like diabetes and heart disease at a younger age,5 therefore it is important that adolescents with obesity have the necessary support to effectively manage their weight.
If approved, Saxenda will be the first EU-approved treatment for obesity in adolescents. Saxenda would be approved for the treatment of adolescents with obesity, with an initial body mass index (BMI) corresponding to 30 kg/m2 for adults and a body weight above 60 kg, in combination with healthy eating and increased physical activity.1 Saxenda is already indicated for weight management in adults with a BMI 30 kg/m2, or 27 kg/m2 with one or more weight-related comorbidity, as an adjunct to a reduced-calorie diet and increased physical activity.6
'The global rise in adolescent obesity is a public health issue and poses a severe challenge for adolescents' living with obesity due to the limited treatment options available,' said
The CHMP opinion is based on the results of a phase 3 trial published last year in the
The CHMP positive opinion is now referred to the
About the phase 3 trial (NCT02918279)
The trial investigated the safety and efficacy of Saxenda (liraglutide 3.0 mg or maximum tolerated dose) compared to placebo for weight management in 251 adolescents (aged 12-17 years) living with obesity as an adjunct to lifestyle therapy. The trial included a 12-week run-in period of lifestyle therapy, a 56-week treatment period (including dose escalation over 4 to 8 weeks) on Saxenda or placebo and a 26-week follow-up period without Saxenda or placebo. All participants received lifestyle therapy beginning with the run-in period and during the 56-week treatment period and 26-week follow-up period.7 The evaluation of Saxenda in the paediatric population was part of the Paediatric Investigation Plan (PIP) for Saxenda, submitted and agreed upon with the EMA Paediatric Committee (PDCO).8,9
About Saxenda
Saxenda (liraglutide 3.0 mg) is a once-daily glucagon-like peptide-1 (GLP-1) analogue with 97% similarity to naturally occurring human GLP-1,6,10 a hormone that is released in response to food intake.11 Like human GLP-1, Saxenda is believed to work in areas of the brain involved in appetite regulation, including the hypothalamus.12 Saxenda for use in adults with obesity was evaluated in the SCALE (Satiety and Clinical Adiposity - Liraglutide Evidence) clinical trial programme. Since launch in 2015, more than 1.5 million patients have been treated with Saxenda globally.13
About obesity
Obesity is a chronic and progressive disease that requires long-term medical management.14,15 One common misunderstanding is that it is a disease of willpower, when in fact there is underlying biology that prevents people from maintaining long-term weight loss.16 Obesity is influenced by a variety of factors, including genetics, altered appetite signals, behaviour as well as the surrounding environment.16 It is a disease that is associated with at least 60 other health conditions.17
About adolescent obesity
Adolescents with obesity are more likely to develop weight-related complications, like diabetes and cardiovascular diseases, at a younger age.5 Just like other chronic diseases, obesity requires long-term management.14,15 80% of adolescents who live with obesity are likely to go on to also have obesity as adults.18 Globally, more than 124 million children and adolescents have obesity.4
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