The Food and Drug Administration (FDA) has approved Wegovy® (semaglutide injection) as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in pediatric patients aged 12 years and older with an initial body mass index (BMI) at the 95th percentile or greater for age and sex (obesity).

Wegovy contains semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist. It works by targeting areas of the brain that regulate appetite and food intake.

The approval was based on data from the STEP TEENS study (ClinicalTrials.gov Identifier: NCT04102189), which included 201 participants 12 to less than 18 years of age with BMI corresponding to greater than or equal to the 95th percentile standardized for age and sex. Patients were randomly assigned 2:1 to receive semaglutide administered once-weekly by subcutaneous injection or placebo for 68 weeks, in addition to lifestyle intervention. The primary endpoint of the study was the percentage change in BMI from baseline to week 68.

At week 68, the mean change in BMI from baseline in the semaglutide group was -16.1%, while in the placebo group, it was 0.6% (estimated difference, -16.7 percentage points [95% CI, -20.3, -13.2]; P <.0001). Compared with placebo, a greater proportion of patients treated with semaglutide achieved a BMI reduction of 5% or more (77.1% vs 19.7%), 10% or more (65.1% vs 7.7%), and 15% or more (57.8% vs 4.0%). In addition to reductions in body weight, improvements in waist circumference, HbA1c, and lipids (except for high-density lipoprotein cholesterol) were also observed with semaglutide compared with placebo.

An analysis of safety data showed that adverse reactions in adolescents were similar to those observed in adults. Nausea, vomiting, diarrhea, headache, and abdominal pain were the most frequently reported adverse reactions. An increased incidence of gallbladder problems (including gallstones), hypotension, rash, and itching was noted in adolescents when compared with adults.

Wegovy is supplied in prefilled, single-dose pens that deliver doses of 0.25mg, 0.5mg, 1mg, 1.7mg, or 2.4mg. According to Novo Nordisk, all dose strengths of Wegovy are now available.

Wegovy is also indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients with an initial BMI of 30kg/m2 or greater (obesity) or 27kg/m2 or greater (overweight) in the presence of at least 1 weight-related comorbid condition (eg, hypertension, type 2 diabetes mellitus, or dyslipidemia).

References

  1. FDA approves once-weekly Wegovy® injection for the treatment of obesity in teens aged 12 years and older. News release. Novo Nordisk. December 23, 2022. Accessed January 3, 2023. https://www.novonordisk-us.com/content/nncorp/us/en_us/media/news-archive/news-details.html?id=151389.
  2. Wegovy. Package insert. Novo Nordisk; 2022. Accessed January 3, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215256s005lbl.pdf.