Novo Nordisk has been given approval from the US Food and Drug Administration (FDA) for an updated label for Saxenda (liraglutide) injection 3 mg for obesity treatment in adolescents in the 12–17 years age group.
The approval is for adolescents who weigh more than 60 kg and have an initial body mass index (BMI) corresponding to 30 kg/m2 or greater for adults.
Saxenda, which is a once-daily glucagon-like peptide-1 (GLP-1) receptor agonist, is intended to be used as an adjunct to reduced-calorie meals and increased physical activity.
It was approved by the FDA in 2014 for chronic weight management in adults having a BMI ≥30 kg/m2, or ≥27 kg/m2 with one or more weight-related comorbidities, as an adjunct to a reduced calorie meal plan and also increased physical activity.
Mads Krogsgaard Thomsen – executive vice president and chief scientific officer of Novo Nordisk said: “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.
“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.”
The safety and efficacy of the GLP-1 receptor agonist as an obesity treatment in adolescents is supported by the findings of a phase 3a trial, which were disclosed to the public earlier this year in the New England Journal of Medicine.
The 56-week clinical trial studied the effects of Saxenda compared to placebo for weight management in 251 obese patients, aged 12-17, as an adjunct to lifestyle therapy.
In the late-stage trial, the primary endpoint was variation from baseline in Body Mass Index (BMI) Standard Deviation Score (SDS) at week 56.