FDA approves Wegovy for adolescents aged 12 and up
The FDA approved Wegovy (semaglutide) for chronic weight management in patients 12 and older with obesity, making the weekly injection a labeled option for adolescents for the first time.
The U.S. Food and Drug Administration approved an expanded label for Wegovy (semaglutide) injection on December 23, 2022, adding use "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 BMI at the 95th percentile or greater standardized for age and sex (obesity)" [1]. The approval letter was signed that evening by John Sharretts, M.D., director of the FDA's Division of Diabetes, Lipid Disorders, and Obesity [1].
What the FDA acted on
Novo Nordisk submitted the supplemental new drug application on June 29, 2022, and the FDA approved it about six months later [1]. The decision was based on trial NN9536-4451, known as STEP TEENS, titled "Effect and safety of semaglutide 2.4 mg once weekly on weight management in adolescents with overweight or obesity" [1]. The study is registered on ClinicalTrials.gov as NCT04102189 [2].
That trial was not optional. When the FDA first approved Wegovy for adults on June 4, 2021, it attached a postmarketing requirement, numbered 4081-1, ordering the company to "complete the ongoing 68-week randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of semaglutide for the treatment of obesity in pediatric patients ages 12 to less than 18" [1]. The December 2022 submission included that study's final report, and the FDA concluded the requirement was fulfilled [1]. The agency also confirmed that the pediatric study requirement under the Pediatric Research Equity Act for ages 12 to under 18 had been met [1].
The approval letter does not contain weight-loss percentages, side effect rates, or the number of teens enrolled. Those specifics are not available in the documents reviewed here, so the size of the benefit seen in STEP TEENS is not something these sources establish.
What the label says
Wegovy injection is given once weekly under the skin of the abdomen, thigh, or upper arm, with or without meals [3]. The product label carries a boxed warning for an increased risk of thyroid C-cell tumors [3]. Other warnings and precautions on the label include acute pancreatitis, acute gallbladder disease, low blood sugar, acute kidney injury, hypersensitivity reactions, diabetic retinopathy complications in people with type 2 diabetes, increased heart rate, and suicidal behavior and ideation [3].
Common side effects reported in at least 5% of adults or pediatric patients aged 12 and older include nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, indigestion, dizziness, bloating, burping, low blood sugar in people with type 2 diabetes, gas, gastroenteritis, acid reflux, and nasopharyngitis [3]. The label also states that using Wegovy alongside other semaglutide-containing products or any other GLP-1 receptor agonist is not recommended [3].
Why it matters for patients
Before this action, Wegovy's weight-management indication covered adults only [1][3]. The expanded label means families and clinicians now have an FDA-reviewed pediatric indication rather than relying on off-label use, and it sets a defined eligibility threshold: a BMI at or above the 95th percentile for age and sex [1]. The indication is written as an add-on to reduced-calorie eating and increased physical activity, not a replacement for them [1].
A labeled pediatric indication also matters for paperwork. Insurers frequently key coverage decisions to FDA-approved uses, though nothing in these sources addresses how payers will handle adolescent coverage or what the drug will cost for teens. Those questions remain open.
What happens next
Under the approval letter, Novo Nordisk had 14 days from December 23, 2022, to submit the final content of labeling — prescribing information, Medication Guide, and Instructions for Use — in structured product labeling format, which then becomes publicly accessible through labeling repositories [1]. The company also had 30 days to submit required patent information for the Orange Book [1].
The FDA noted that other postmarketing requirements listed in the June 4, 2021, approval letter remain open [1]. The agency did not say in this letter when those are due.
Sources
Semaglutides.org is for information only and is not medical advice. Always talk to a licensed healthcare provider about your own care. Some links to telehealth services are affiliate links, labeled where they appear.