FDA Approves Weight Loss Drug Wegovy for Teens
The FDA recently approved Wegovy (semaglutide), a GLP-1 receptor agonist, as a weight loss treatment for teens ages 12 and up. Wegovy is now the first once-weekly weight loss drug approved for adolescents.
A significant milestone to bring in the new year, the FDA approved Wegovy (semaglutide) on Dec. 23, 2022, for teens ages 12 and up who have a BMI at or above the 95th percentile for their age and sex.
The drug was originally approved for adults with obesity in June 2021. Since then, Wegovy has become one of the most popular prescription weight loss drugs, leading to a supply shortage towards the end of 2022. On Jan. 3, Novo Nordisk announced that it had worked through these issues and plans to increase production in 2023.
Semaglutide, which is also available under the brand names Ozempic and Rybelsus, is a GLP-1 receptor agonist that has been shown to help people with type 2 diabetes lose weight, lower glucose levels, and protect against diabetes-related heart complications.
Obesity rates in adolescents ages 12-19 have gone up significantly over the past five years, with researchers predicting even greater increases in the near future. In a study recently published by the American Diabetes Association, researchers predict a staggering increase in the number of people diagnosed with diabetes under age 20; models suggest a nearly 700% increase in youth with type 2 diabetes.
Obesity during childhood and adolescence not only increases the risk of developing type 2 diabetes but also rapidly accelerates the progression of diabetes-related complications such as chronic kidney disease and various heart conditions.
“This new research should serve as a wake-up call for all of us,” said Dr. Debra Houry, acting deputy director of the CDC, in a recent press release. “It’s vital that we focus our efforts to ensure all Americans, especially our young people, are the healthiest they can be.”
The new indication for Wegovy follows results from the STEP TEENS clinical trial, a phase 3 study that included 201 teens ages 12 to 17, all but one of whom had a BMI at or above the 95th percentile for their age and sex. By the end of the 68-week trial, participants taking Wegovy saw an average decrease of 16.1 percentage points in their BMI percentile compared with the placebo group, whose average BMI percentile increased by 0.6 percentage points. Of those who received Wegovy, 73% lost at least 5% of their starting body weight by the end of the study.
Wegovy is the first once-weekly GLP-1 receptor agonist approved as a weight loss medication for people under the age of 18. Other GLP-1 receptor agonists, including Victoza (liraglutide) and Bydureon-BCise (exenatide), are available as once-daily injections for adolescents who have been diagnosed with type 2 diabetes. Saxenda (liraglutide 3 mg), a once-daily injection, is also FDA-approved as a weight loss treatment for teens with or without type 2 diabetes. Qsymia, a once-daily oral medication that is not a GLP-1 receptor agonist, is also indicated as an obesity treatment for adolescents aged 12-17.
“Now, more than ever, we need new options to support teens,” said Aaron S. Kelly, co-director of the Center for Pediatric Obesity Medicine at the University of Minnesota, in a press release from Novo Nordisk. “This FDA approval offers an additional tool to address this serious, chronic, progressive disease.”
In addition to the usual safety information for this class of medications, the product label suggests discontinuing Wegovy before attempting pregnancy (for both females and males), and stopping if an unplanned pregnancy occurs.
For more about Wegovy, type 2 diabetes, and obesity in childhood and adolescence: