FDA adds a pediatric weight-management indication to Wegovy

The FDA expanded the approved use of Wegovy (semaglutide) injection on Dec. 23, 2022, to include chronic weight management in patients 12 and older who have obesity ^[1][3]. The approval letter was signed that day by John Sharretts, M.D., director of the agency's Division of Diabetes, Lipid Disorders, and Obesity ^[1].

As written into the prescribing information, the new indication covers use "as an adjunct to a reduced calorie diet and increased physical activity" in pediatric patients 12 years and older whose starting BMI is at or above the 95th percentile, standardized for age and sex ^[1]. That percentile cutoff is the adolescent measure of obesity; it is not the same as an adult BMI number.

Novo Nordisk filed the supplemental new drug application for the change on June 29, 2022 ^[1].

The evidence came from a study the letter calls NN9536-4451, or STEP TEENS, titled "Effect and safety of semaglutide 2.4 mg once weekly on weight management in adolescents with overweight or obesity" ^[1]. A ClinicalTrials.gov record lists the same work as NCT04102189, "A Research Study on How Well Semaglutide Works in Adolescents With Overweight or Obesity" ^[2]. The trial ran 68 weeks, was randomized and double-blind, used a placebo comparison, and enrolled patients aged 12 to less than 18 ^[1]. Weight-loss results from the trial are not included in the approval letter or the study record's summary page.

The FDA said the application satisfied postmarketing requirement 4081-1, which had asked the company to complete the 68-week pediatric study, and that Novo Nordisk "fulfilled the pediatric study requirement for ages 12 to less than 18 years" ^[1]. The letter notes that other postmarketing requirements tied to the June 4, 2021, approval remain open, without listing them or giving due dates ^[1].

Wegovy is a glucagon-like peptide-1 (GLP-1) receptor agonist given as a once-weekly injection under the skin ^[3]. Its labeling carries a boxed warning about an increased risk of thyroid C-cell tumors, and warnings about acute pancreatitis, gallbladder disease, low blood sugar, kidney injury and other problems ^[3]. Side effects listed as common in adults and in patients 12 and older include nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, indigestion, dizziness, abdominal bloating, belching, gas and nasopharyngitis ^[3].

Why it matters for patients

Until this action, the weight-management indication on Wegovy's label named adults only; the first approval came June 4, 2021 ^[3]. With the December 2022 change, the label itself names adolescents 12 and older, and it sets a clear eligibility line — an initial BMI at or above the 95th percentile for age and sex — rather than leaving the age group unaddressed ^[1].

The new indication applies to Wegovy injection. The FDA letter does not address other semaglutide products, which have their own separate approvals and labeled uses ^[1].

Several practical questions have not been answered in these documents: whether health plans cover the drug for adolescents, what it costs for that age group, and how many U.S. teenagers meet the 95th-percentile threshold. Long-term safety and weight outcomes for people who start the medication at 12 or 13 have not been reported.

What happens next

The letter directed Novo Nordisk to file updated labeling in structured product labeling format within 14 days, and to submit required patent information on Form FDA 3542 within 30 days ^[1]. It also states that postmarketing requirements from the June 4, 2021, letter are still open, without describing their scope ^[1]. Nothing in these documents indicates when or whether full STEP TEENS results will be published.