FDA approves Saxenda, first GLP-1 for weight management in adolescents 12 and older

The FDA approved Saxenda (liraglutide 3.0 mg) on December 4, 2020, for weight management in patients aged 12 and older with obesity. It became the first GLP-1 receptor agonist approved in the United States for weight management in a pediatric age group. The decision was based on the 56-week SCALE TEENS randomized trial, which enrolled 251 adolescents with obesity.

Before that approval, weight-management use of GLP-1 receptor agonists was limited to adults. The adolescent indication covers patients 12 and older with obesity. The trial's full results, including average weight change and how many participants stayed on the drug, have not been disclosed.

Since then, pediatric obesity care has been reshaped by a clinical practice guideline from the American Academy of Pediatrics, published in the February 2023 issue of Pediatrics ^[1]. That guideline describes obesity as a complex chronic disease and says children and adolescents with overweight or obesity should be offered treatment when the diagnosis is made ^[2]. It states that 14.1 million children and adolescents in the United States are affected by obesity ^[2].

The AAP guideline recommends measuring height and weight, calculating BMI and assessing BMI percentile at least yearly for all children aged 2 to 18, and it calls for evaluating children with overweight (BMI at or above the 85th percentile to below the 95th percentile) or obesity (BMI at or above the 95th percentile) for related conditions. That evaluation includes patient history, mental and behavioral health screening, social determinants of health, physical examination and diagnostic tests ^[2]. The guideline lists type 2 diabetes, hypertension, sleep apnea, nonalcoholic fatty liver disease and depression among the conditions linked to overweight and obesity in children ^[2].

Prevalence figures presented with the guideline show obesity affecting 20.6% of US youth aged 12 to 19, 18.4% of those aged 6 to 11 and 13.9% of those aged 2 to 5, based on national survey data from 2015-2016 ^[2]. The guideline was built from roughly 16,000 abstracts, 1,642 full-text articles and 382 included studies, producing 13 key action statements and 11 consensus recommendations ^[2].

Why it matters for patients

The approval gave families with an adolescent with obesity a medication option in a drug class that previously had only adult weight-management indications. It also placed GLP-1 drugs inside the clinical pathway the AAP later described for pediatric obesity: screening, full evaluation, then treatment offered at diagnosis rather than after a waiting period ^[1][2].

That pathway is wider than medication. The guideline's treatment section covers intensive health behavior and lifestyle treatment and says pediatricians should treat overweight or obesity and related conditions at the same time ^[1][2]. It also includes a section stating that evidence-based pediatric obesity treatment reduces risks for disordered eating ^[1].

Access is a separate question. Whether insurers cover GLP-1 weight-management drugs for adolescents, what prior authorization rules apply, and whether age limits differ by plan have not been reported. The guideline notes that obesity in children is often tied to structural factors such as limited food access, lower socioeconomic status, exposure to structural racism and neighborhood conditions ^[2], all of which shape what treatment a family can actually get.

What happens next

Current US pediatric guidance dates to February 2023, when the AAP clinical practice guideline was published in Pediatrics ^[1]. Because SCALE TEENS ran 56 weeks, safety and weight outcomes in adolescents beyond that window have not been disclosed. It also has not been reported whether any other GLP-1 medication since received a US weight-management approval for patients aged 12 and older.