Saxenda can be used in adolescents with an initial BMI corresponding to ≥30 kg/m2 and a body weight above 60kg, in combination with healthy eating and increased physical activity.
Further informationView Saxenda drug record
'Interventions to treat the rise in adolescent obesity are much needed, and this approval offers hope to families and clinicians supporting adolescents with their efforts to manage their weight,' said Senthil Senniappan, consultant paediatric endocrinologist at Alder Hey Children’s Hospital.
'Many adolescents struggle to lose weight through lifestyle interventions alone and unfortunately we know that adolescents living with obesity typically go on to become adults living with obesity, substantially increasing their risk of early morbidity and mortality. I’m encouraged to see the positive results of clinical trials among adolescents, as this option will allow clinicians to further customise weight loss plans for adolescents, in cases where greater support is clinically necessary.'
Saxenda is a once-daily glucagon-like peptide-1 (GLP-1) analogue given by subcutaneous injection at a dose of up to 3mg daily. It is already indicated for weight management in adults with a BMI ≥30kg/m2, or ≥27kg/m2 with one or more weight-related comorbidity, as an adjunct to a reduced-calorie diet and increased physical activity.
Approval of Saxenda for use in adolescents is based on the results of a phase III trial published last year in the New England Journal of Medicine.
The trial investigated the safety and efficacy of liraglutide 3mg (or maximum tolerated dose) compared with placebo for weight management in adolescents aged 12–17 years living with obesity (n=251), 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 liraglutide or placebo and a 26-week follow-up period without liraglutide or placebo. Lifestyle therapy continued throughout.
Results showed that liraglutide was superior to placebo with regard to the primary endpoint: change from baseline in the BMI standard-deviation score at week 56 (estimated difference −0.22; 95% CI −0.37 to −0.08; p=0.002). A reduction in BMI of at least 5% was observed in 51 of 113 participants in the liraglutide group and in 20 of 105 participants in the placebo group (estimated percentage 43.3% vs. 18.7%), and a reduction in BMI of at least 10% was observed in 33 and 9 participants, respectively (estimated percentage 26.1% vs. 8.1%).
A greater reduction was observed with liraglutide than with placebo for BMI (estimated difference −4.64 percentage points) and for body weight (estimated difference −4.50kg [for absolute change] and −5.01 percentage points [for relative change]).
The safety profile of liraglutide 3mg in adolescents was similar to that observed in adults, with the most common adverse events being gastrointestinal. There were also more hypoglycaemic events recorded with liraglutide than with placebo and patients should be informed about the characteristic symptoms of hypoglycaemia and the appropriate actions to take if this occurs.