FDA approves liraglutide for treating obesity in adolescents
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The FDA approved an updated label for liraglutide 3 mg for use in the treatment of obesity in adolescents aged 12 to 17 years with a body weight of at least 60 kg and an initial BMI corresponding to 30 kg/m² or greater for adults.
The GLP-1 receptor agonist liraglutide (Saxenda, Novo Nordisk) is available in an injector pen for daily use. The 3 mg daily dose was approved in 2014 for chronic weight management in adults with a BMI of at least 30 kg/m², or at least 27 kg/m² with at least one weight-related comorbidity, as an adjunct to a reduced calorie meal plan and increased physical activity. With the updated label, liraglutide 3 mg is the first FDA-approved therapy for adolescents with obesity in more than a decade.
"New options to treat adolescents who live with obesity can bring much-needed hope to families and help address this growing epidemic," Aaron S. Kelly, PhD, professor in the department of pediatrics and a co-director of the Center for Pediatric Obesity Medicine at the University of Minnesota Medical School in Minneapolis, said in a press release. "With up to 90% 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 health care providers now have another tool in developing a personalized, complete care plan to help adolescents lose weight and keep it off."
As Healio previously reported, adolescents with obesity who did not respond to lifestyle therapy saw a greater reduction in BMI standard deviation score during a 1-year intervention with liraglutide 3 mg compared with similar adolescents assigned placebo. At 56 weeks, researchers found that liraglutide was superior to placebo for change from baseline in BMI SDS, with an estimated treatment difference of –0.22 (95% CI, –0.37 to –0.08). The findings from a randomized controlled trial were presented at the Endocrine Society Annual Meeting and published in The New England Journal of Medicine in April.
Additionally, compared with those assigned placebo, more participants in the liraglutide group experienced at least a 5% reduction in BMI (43.3% vs. 18.7%) and at least a 10% reduction in BMI (26.1% vs. 8.1%) during the study. BMI reduction was greater among adolescents assigned liraglutide vs. placebo, with an estimated difference of –4.64 percentage points at 56 weeks (95% CI, –7.14 to –2.14). Similarly, loss of body weight was greater in the liraglutide group vs. placebo, with an estimated difference of –4.5 kg for absolute change and –5.01 percentage points for relative change.
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," Mads Krogsgaard Thomsen, executive vice president and chief scientific officer of Novo Nordisk, said in the release. "We are proud to be able to offer a new treatment option for adolescents with obesity and their families in the U.S., as the FDA approval marks another significant milestone for Saxenda."
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