With the updated label, liraglutide is the first FDA-approved therapy for adolescents with obesity in over a decade.
The US Food and Drug Administration (FDA) approved an updated label for liraglutide 3 mg (Saxenda®, Novo Nordisk) for use in the treatment of obesity in adolescents aged 12-17 years weighing >60 kg and with an initial body mass index (BMI) corresponding to ≥30 kg/m2 for adults, as an adjunct to reduced-calorie meals and increased physical activity.
Liraglutide is a glucagon-like peptide-1 receptor agonist available in an injector pen for daily use.
Liraglutide was originally approved in 2014 for chronic weight management in adults with a BMI ≥30 kg/m2 with at least 1 weight-related comorbidity, as an adjunct to a reduced calorie meal plan and increased exercise. With the updated label, liraglutide is the first FDA-approved therapy for adolescents with obesity in more than 10 years.
"New options to treat adolescents who live with obesity can bring much-needed hope to families and help address this growing epidemic," said Aaron Kelly, PhD, professor, Department of Pediatrics, co-director, Center for Pediatric Obesity Medicine, University of Minnesota, in a Novo Nordisk press release. "With up to 90 percent of adolescents with obesity likely to have it as adults and thus at increased risk for developing weight-related complications, it's important to address weight care and offer support early on. I'm encouraged that healthcare providers now have another tool in developing a personalized, complete care plan to help adolescents lose weight and keep it off."
The safety and efficacy of liraglutide as a treatment for adolescents with obesity was based on the results from a phase 3a trial led by Kelly and colleagues published in the May issue of the New England Journal of Medicine.
The double-blind, 56-week clinical trial examined the effects of liraglutide vs placebo for weight management in 251 patients aged 12-17 years with obesity as an adjunct to lifestyle therapy, defined as counselling in healthy nutrition and physical activity for weight loss.
Participants were randomly assigned to receive either 3 mg of liraglutide or placebo subcutaneously once daily, in addition to lifestyle therapy. The primary endpoint was the change from baseline in BMI standard-deviation score (BMI-SDS) at week 56.
The results showed a significant reduction in BMI-SDS, as well as reductions in BMI, mean body weight, and other weight-related endpoints among participants who received liraglutide vs placebo.
Adverse events seen in this adolescent population were similar to those observed in adults, the most common being gastrointestinal events, including nausea, vomiting and diarrhea.