Wegovy Approval for Pediatric Use
Yes, Wegovy (semaglutide 2.4 mg) is FDA-approved for use in patients aged 12 years and older with obesity. 1
FDA-Approved Age Range
Wegovy is approved for adolescents aged 12 years and older who have a body mass index (BMI) in the 95th percentile or higher (obesity), or in the 85th percentile or higher (overweight) with at least one weight-related coexisting condition 1, 2
The FDA drug label for semaglutide (Ozempic formulation) explicitly states that "safety and efficacy of OZEMPIC have not been established in pediatric patients (younger than 18 years)" 3, but this refers specifically to the diabetes indication, not the weight management indication under the Wegovy brand
Clinical Evidence Supporting Pediatric Use
The STEP TEENS trial (2022) demonstrated that adolescents aged 12 to <18 years with obesity treated with once-weekly subcutaneous semaglutide 2.4 mg achieved a mean BMI reduction of -16.1% compared to 0.6% with placebo at 68 weeks 2
In the STEP TEENS trial, 73% of adolescents in the semaglutide group achieved ≥5% weight loss compared to 18% in the placebo group 2
Gastrointestinal adverse events occurred in 62% of adolescents treated with semaglutide versus 42% with placebo, and 4% developed cholelithiasis (gallstones) 2
Important Clinical Considerations
The approval is specifically for the Wegovy brand (2.4 mg dose) for weight management, not for the Ozempic brand used for diabetes treatment 1, 4
Treatment must be combined with lifestyle intervention for optimal results 2
The drug has not been studied in children younger than 12 years of age 2