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Novo Nordisk has announced their product Wegovy received approval from the US Food and Drug Administration for use in adolescents aged 12 years and older with obesity.
The US Food and Drug Administration (FDA) has approved semaglutide (Wegovy; Novo Nordisk) for treating obesity in pediatric patients aged 12 years and older.
The approval was granted following the results of a phase 3a study, which have been published in the New England Journal of Medicine. Participants in the trial were given semaglutide or placebo for 68 weeks alongside lifestyle intervention. Safety, efficacy, and tolerability were compared between these 2 groups.
Mean percentage change in body mass index (BMI) at week 68 was the primary endpoint of the trial. The mean change in BMI was a 16.1% decrease for the semaglutide group compared to a 0.6% increase for the placebo group.
A BMI reduction of 5% or more was the secondary endpoint of the trial. This was met by 77% of patients taking semaglutide and 20% of patients taking placebo.
Adverse reactions in adolescents taking semaglutide matched those of adults, with the most common reactions including headache, abdominal pain, nausea, vomiting, and diarrhea. Adolescents saw an increased incidence of gallbladder problems compared to adults, including gallstones, low blood pressure, rash, and itching.
The recommended dose of semaglutide in pediatric patients is 2.4 mg, and it should be used alongside a reduced-calorie meal plan and increased physical activity to treat obesity. Semaglutide should not be taken alongside other semaglutide-containing products or GLP-1 receptors.
Obesity is a long-term and severe disease that is often met with misunderstanding. While many individuals believe obesity can be treated through willpower, there are often biological aspects which make it difficult to reduce and retain lost weight. Genetics, socioeconomic factors, and environment all contribute to obesity in adolescents.
Outcomes of obesity include high blood pressure, high cholesterol, and type 2 diabetes. The prevalence of obesity has increased worldwide, making options for treatment more important than ever.
FDA approves once-weekly Wegovy injection for the treatment of obesity in teens aged 12 years and older. Novo Nordisk USA. December 23, 2022. Accessed January 3, 2023. https://www.novonordisk-us.com/media/news-archive/news-details.html?id=151389