FDA approves Saxenda for the treatment of obesity in adolescents
Novo Nordisk has received FDA approval for an updated label for Saxenda (liraglutide) injection 3mg for use in the treatment of obesity in adolescents (12–17 years) with a body weight above 60kg and an initial body mass index (BMI) corresponding to 30 kg/m2 or greater for adults, as an adjunct to reduced-calorie meals and increased physical activity. Saxenda was approved in 2014 for chronic weight management in adults with a BMI ≥30 kg/m2, or ≥27 kg/m2 with at least one weight-related comorbidity, as an adjunct to a reduced calorie meal plan and increased physical activity.
Saxenda (liraglutide) injection 3.0mg is a once-daily glucagon-like peptide-1 (GLP-1) receptor agonist with 97% similarity to naturally occurring human GLP-1, a hormone that is involved in appetite regulation and food intake. Like human GLP-1, Saxenda is believed to work in areas of the brain involved in appetite regulation, including the hypothalamus.
Over the last 20 years, the global prevalence of children and adolescents with excess weight has doubled from one in ten to one in five. Research also shows that when both parents have excess weight, 80% of their children will have obesity. However, current treatment options for this population are limited, highlighting a considerable and growing need for additional treatment strategies.
"New options to treat adolescents who live with obesity can bring much-needed hope to families and help address this growing epidemic," said Dr Aaron Kelly, Professor of Pediatrics and co-director of the Center for Pediatric Obesity Medicine at the University of Minnesota. "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 Saxenda as a treatment for adolescents with obesity is supported by data from a phase 3a trial published in May 2020 in the New England Journal of Medicine (A Randomized, Controlled Trial of Liraglutide for Adolescents with Obesity). The 56-week clinical trial investigated the effects of Saxenda compared to placebo for weight management in 251 patients aged 12-17 living with obesity as an adjunct to lifestyle therapy, defined as counselling in healthy nutrition and physical activity for weight loss. In the trial, the primary endpoint was change from baseline in BMI Standard Deviation Score (SDS) at week 56.
The data demonstrated a significant reduction in BMI-SDS, as well as reductions in BMI, mean body weight, and other weight-related endpoints vs. placebo in adolescents with obesity when using Saxenda®as an adjunct to lifestyle therapy. Adverse events seen in an adolescent population were similar to those observed in adults. The most common adverse reactions were gastrointestinal events, including nausea, vomiting and diarrhea.
"The rise in adolescent obesity is contributing to a public health crisis, and it poses a real challenge for healthcare professionals due to the limited treatment options available," said Mads Krogsgaard Thomsen, executive vice president and chief scientific officer of Novo Nordisk. "We are proud to be able to offer a new treatment option for adolescents with obesity and their families in the US, as the FDA approval marks another significant milestone for Saxenda."
Since launching in 2015, more than 1.5 million patients have been treated with Saxenda globally.
To access the New England Journal of Medicine paper, please click here