FDA approves injectable semaglutide for people with obesity ages 12 and more

The U.S. Food and Drug Administration (FDA) has approved a new indication for Wegovy (semaglutide) injection 2.4 mg, making it the first-and-only prescription anti-obesity medicine for teens with once-weekly dosing.

As announced by Novo Nordisk, Wegovy® is now also indicated for use in adolescents (≥ 12 years old) with an initial BMI at or above the 95th percentile for age and sex (based on CDC growth charts) along with a reduced calorie meal plan and increased physical activity to lose weight and keep it off.

Obesity is a disease that can start in childhood or adolescence, and up to 90 percent of teenagers with obesity may continue to live with obesity into adulthood. Teens with obesity are at a greater risk of developing serious weight-related health problems.

The safety and efficacy of Wegovy® as a treatment for adolescents with obesity is supported by data from a phase 3a study recently published in the New England Journal of Medicine.

In the STEP TEENS clinical trial, 201 adolescents were given either Wegovy® (n=134 adolescents) or placebo (n=67 adolescents) once a week for 68 weeks in addition to lifestyle intervention, to compare effectiveness, safety, and tolerability. Wegovy® was superior to placebo in terms of the trial’s primary endpoint, mean percentage change in BMI at week 68 (16.1% decrease vs 0.6% increase). In addition, as a supportive secondary endpoint, 77% of patients taking Wegovy® experienced a BMI reduction of greater than or equal to 5%, compared with 20% taking placebo.

“The prevalence of teen obesity in the U.S. continues to rise, affecting teens and their families. Now, more than ever, we need new options to support teens,” said Aaron S. Kelly, PhD, Co-Director of the Center for Pediatric Obesity Medicine at the University of Minnesota. “This FDA approval offers an additional tool to address this serious, chronic, progressive disease.”

Adverse reactions with Wegovy® treatment in adolescents 12 years of age and older were similar to those reported in adults. Adolescents treated with Wegovy® had greater incidences of gallbladder problems including gallstones, low blood pressure, rash, and itching compared to adults treated with Wegovy®. The most frequently reported adverse reactions were nausea, vomiting, diarrhea, headache, and abdominal pain.

Reference:

Daniel Weghuber, Timothy Barrett, Margarita Barrientos-Pérez, Inge Gies, Dan Hesse, Ole K. Jeppesen, Aaron S. Kelly, Lucy D. Mastrandrea, Rasmus Sørrig, and Silva Arslanian, N Engl J Med 2022; 387:2245-2257 DOI: 10.1056/NEJMoa2208601