FDA Approves Semaglutide for Pediatric Patients

In the first big pharmaceutical development of 2023, Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for semaglutide as the first injectable antiobesity prescription medication for use in pediatric patients.

 

Manufactured by Novo Nordisk and sold under the brand name Wegovy, semaglutide is a glucagon-like-peptide-1(GLP-1) agonist which was first approved by the FDA to treat diabetes and obesity or overweight in adults. The expanded label now includes its use in adolescents 12 years or older, with an initial body mass index (BMI) at or above the 95th percentile for age and sex. Its use is advised along with a reduced-calorie meal plan and increased physical activity.

STEP TEENS

This label expansion is based on promising results of the recent STEP TEENS trial, first announced in a much-anticipated session last November at ObesityWeek 2022. The double-blind, parallel-group, randomized and placebo-controlled 68-week clinical trial compared the effects of a subcutaneous 2.4 mg once-weekly semaglutide injection versus placebo in 201 adolescents with obesity. Subjects in both the study and placebo groups also received behavioral lifestyle therapy focusing on healthy diet and exercise.

“Semaglutide 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 semaglutide (Wegovy) experienced a BMI reduction of greater than or equal to 5%, compared with 20% taking placebo.” – Study investigators

Pediatric obesity

In the U.S., an estimated 1 in 5 adolescents between the ages of 12 and 19 have the disease of obesity. Obesity in adolescents is influenced by a variety of factors that include genetics, socioeconomic and environmental factors. This serious, chronic, progressive and misunderstood disease requires long-term management to prevent the development of weight-related problems like high blood pressure, high cholesterol, type 2 diabetes, and many others. It is not a disease of willpower; there are underlying biological and societal mechanisms that impede weight loss in the pediatric population.

Expert perspectives

“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. This FDA approval offers an additional tool to address this serious, chronic, progressive disease.” – Aaron S. Kelly, PhD, co-director of the Center for Pediatric Obesity Medicine at the University of Minnesota

“It is one of the most effective treatments available for either condition, outside of bariatric surgery. Moreover, there is evidence that the use of semaglutide may reduce the risk for developing diabetes and may be particularly useful in individuals who have prediabetes.” – Kathleen Dungan, MD, endocrinologist in the Division of Endocrinology, Diabetes & Metabolism at The Ohio State University Wexner Medical Center

“The drug works by making people feel full sooner and suppressing the appetite so people do not feel as hungry. One of the ways it does this is by slowing emptying of the stomach so there is a feeling of satiety.” Ibiye Owei, MD, assistant professor at Texas Tech University Health Sciences Center

 

Related articles:

Recognizing and Treating Obesity as a Disease

ObesityWeek 2022: Semaglutide Shows Promise in Adolescents

Sources:

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