The U.S. Food and Drug Administration (FDA) approved Novo Nordisk‘s weight-loss medication Wegovy for patients ages 12 and up, making it the only prescription anti-obesity drug for teens with once-weekly dosing.

According to the Danish multinational pharmaceutical company – which maintains its U.S. headquarters in Plainsboro – the medicine is authorized for use in adolescents with an initial body mass index (BMI) at or above the 95th percentile for age and sex, based on the U.S. Centers for Disease Control and Prevention (CDC) growth charts.

Wegovy, a semaglutide-based drug, was first approved in June 2021 specifically for chronic weight management in adults who are obese or overweight with at least one weight-related condition, such as high blood pressure, Type 2 diabetes or high cholesterol.

The drug, which is given through injector pens in a once-weekly dosing, should be paired with diet and exercise changes as a way to lose weight and keep it off, according to Novo Nordisk.

For teens, the recommended dose of 2.4 mg is meant to be used alongside a reduced-calorie meal plan and increased physical activity. Additionally, it should not be taken with other semaglutide-containing products or GLP-1 receptors, the FDA said.

The approval for pediatric patients was granted following the results of a clinical trial conducted between November 2021 and March 2022 at the University of Minnesota involving 201 adolescents with obesity.

After 68 weeks of treatment, BMI declined an average 16.1% from baseline with semaglutide versus a 0.6% increase in the placebo group. Mean weight loss was about 33.7 pounds among teens on semaglutide while those on placebo gained 5.3 pounds at 68 weeks.

Altogether, 73% of the patients taking Wegovy saw a weight loss of 5% or more compared with 18% of participants in the placebo group, the study said.

Adverse reactions in adolescents who received the medication matched those of adults, with the most common side effects including headache, nausea, vomiting, abdominal pain and diarrhea. Pediatric patients also reported an increased incidence of gallbladder issues such as gallstones, rashes, low blood pressure and itching.

In a statement, Dr. Aaron Kelly, co-director of the Center for Pediatric Obesity Medicine at the University of Minnesota, applauded the FDA’s approval, saying it “offers an additional tool to address this serious, chronic, progressive disease.”

“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,” Kelly said.

Throughout 2022, Novo Nordisk has been faced with short-term manufacturing issues and unprecedented demand for Wegovy, prompting the company to take several steps to resolve shortages. 

In a Dec. 28 update, Novo Nordisk stated that all dose strengths of Wegovy “are now available to retail pharmacies nationwide” and that it is “increasing our production capacity in 2023, closely monitoring prescribing trends and assessing demand.”