The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved a licence extension for Saxenda (Novo Nordisk) for the treatment of obesity in adolescents aged 12–17 years. As the first UK-approved treatment for this age group, Saxenda can be used in adolescents with an initial body mass index (BMI) corresponding to ≥30 kg/m2 and a body weight above 60kg, in combination with healthy eating and increased physical activity.
Saxenda (liraglutide 3.0mg) is a once-daily glucagon-like peptide-1 (GLP-1) analogue with 97% similarity to naturally occurring human GLP-1, a hormone that is released in response to food intake. Like human GLP-1, Saxenda is believed to work in areas of the brain involved in appetite regulation, including the hypothalamus. 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.
The UK has one of the highest rates of childhood obesity, with almost one in five children living with obesity by the time they leave primary school. Adolescent obesity has a significant impact on physical and mental health, and increases the risk of developing weight-related complications, like diabetes and heart disease, at a younger age. While lifestyle interventions are the first line treatment for childhood obesity, there is a growing need for additional evidence-based solutions in the UK.
“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, 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.”
The MHRA approval is based on the results of a phase 3 trial published last year in the New England Journal of Medicine, which demonstrated a significant reduction in Body Mass Index (BMI) Standard Deviation Score (SDS), and reduction in BMI, body weight and other weight-related endpoints in adolescents with obesity, when using Saxenda as an adjunct to lifestyle therapy.
The trial investigated the safety and efficacy of Saxenda (liraglutide 3.0mg or maximum tolerated dose) compared to placebo for weight management in 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 four to eight 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. The evaluation of Saxenda in the paediatric population was part of the Paediatric Investigation Plan (PIP) for Saxenda, submitted and agreed upon with the European Medicines Agency Paediatric Committee (PDCO).