Fri, 23 Dec 2022 19:36:00 -0500
Fri, 23 Dec 2022 19:36:00 -0500
PLAINSBORO, NJ, December 23, 2022 – Novo Nordisk today announced that 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. 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.1
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.4,5 Teens with obesity are at a greater risk of developing serious weight-related health problems.6
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.1
“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.1
Novo Nordisk is on track to make all dose strengths of Wegovy® available in the U.S. by the end of the year. For further information, please visit www.Wegovy.com.
What is Wegovy®?
Wegovy ® (semaglutide) injection 2.4 mg is an injectable prescription medicine that may help adults and children aged 12 years and older with obesity, or some adults with excess weight (overweight) who also have weight-related medical problems to help them lose weight and keep the weight off.
Important Safety Information
What is the most important information I should know about Wegovy®?
Wegovy® may cause serious side effects, including:
Do not use Wegovy® if:
Before using Wegovy®, tell your healthcare provider if you have any other medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Wegovy ® may affect the way some medicines work and some medicines may affect the way Wegovy ® works. Tell your healthcare provider if you are taking other medicines to treat diabetes, including sulfonylureas or insulin. Wegovy ® slows stomach emptying and can affect medicines that need to pass through the stomach quickly.
What are the possible side effects of Wegovy®?
Wegovy® may cause serious side effects, including:
The most common side effects of Wegovy® may include: nausea, diarrhea, vomiting, constipation, stomach (abdomen) pain, headache, tiredness (fatigue), upset stomach, dizziness, feeling bloated, belching, gas, stomach flu, heartburn, and runny nose or sore throat.
Please see Prescribing Information , including Medication Guide, at https://www.novo-pi.com/wegovy.pdf 1,7
About STEP TEENS trial
STEP TEENS is a phase 3a, double-blind, parallel-group, randomized and placebo-controlled 68-week clinical trial comparing the effects of semaglutide subcutaneous 2.4 mg once weekly versus placebo in 201 adolescents (12 to <18 years old) with obesity. The adolescents in the study and their caregivers also received behavioral lifestyle therapy about healthy food choices and how to be more physically active.1
Wegovy® is currently approved for chronic weight management as an adjunct to meal planning and increased physical activity in the US, the UK, the EU, Canada and other countries, and is under review by several other health authorities.1,8-11
Obesity is a serious chronic, progressive and misunderstood disease that requires long term management.12 One key misunderstanding is that this is a disease of willpower, when in fact there is underlying biology that impedes people from losing weight and keeping it off.13 Adolescent obesity is influenced by a variety of factors, including genetics, socioeconomic factors, and the environment.13-15 Obesity is associated with weight-related problems, including high blood pressure, high cholesterol, and type 2 diabetes.16
The global increase in the prevalence of obesity is a public health issue that has severe cost implications to healthcare systems.17,18 In the United States, about 42% of adults live with obesity, and one out of five teens between the ages of 12-19 live with obesity.2,19
About Novo Nordisk
Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 50,800 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com , Facebook , Twitter , LinkedIn and YouTube .
Allison Schneider (US)
+1 732 513 4875
Mark Joseph Root (US)
+1 848 213 3219
Questions from non-U.S. media should be directed to MediaRelations@novonordisk.com.
 Wegovy® (semaglutide) injection 2.4 mg Prescribing Information. Plainsboro, NJ: Novo Nordisk Inc.; December 2022.
 Centers for Disease Control and Prevention. Childhood obesity facts. Last accessed: December 2022. Available at: https://www.cdc.gov/obesity/data/childhood.html.
 Fryar CD, Carroll MD, Afful J. Prevalence of overweight, obesity, and severe obesity among children and adolescents aged 2–19 years: United States, 1963–1965 through 2017–2018. NCHS Health E-Stats. 2020
 Lifshitz F. Obesity in children. J Clin Res Pediatr Endocrinol.. 2008;1(2):53-60.
 Gordon-Larsen P, The NS, Adair LS. Longitudinal trends in obesity in the United States from adolescence to the third decade of life. Obesity (Silver Spring). 2010;18(9):1801-1804.
 Spear BA, Barlow SE, Ervin C, et al. Recommendations for treatment of child and adolescent overweight and obesity. Pediatrics. 2007;120 Suppl 4:S254-S288. doi:10.1542/peds.2007-2329F
 Wegovy® (semaglutide) injection 2.4 mg Important Safety Information. Plainsboro, NJ: Novo Nordisk Inc.; 2022.
 MHRA. Wegovy® UK summary of product characteristics. Last accessed: December 2022. Available at: https://mhraproducts4853.blob.core.windows.net/docs/2bb95561711e1dff3133e19361ff8e7d5f4fc973.
 EMA. Wegovy® summary of product characteristics. Last accessed: December 2022. Available at: https://www.ema.europa.eu/en/documents/product-information/wegovy-epar-product-information_en.pdf.
 Wegovy™ (semaglutide injection) product Monograph. Novo Nordisk Canada Inc.; June 2022.
 Wegovy® (semaglutide) solution for injection Product Information. Novo Nordisk Pharmaceuticals Pty Ltd.; December 2022.
 World Health Organization. WHO consultation on obesity (1999: Geneva, Switzerland) & World Health Organization. (2000). Obesity: preventing and managing the global epidemic: report of a WHO consultation. Last accessed: December 2022. Available at: https://apps.who.int/iris/handle/10665/42330.
 Wright SM, Aronne LJ. Causes of obesity. Abdom Imaging. 2021;37(5):730-732.
 Centers for Disease Control and Prevention. Causes of obesity. Last accessed: December 2022. Available at: https://www.cdc.gov/obesity/basics/causes.html.
 Lee JS, Jin MH, Lee HJ. Global relationship between parent and child obesity: a systematic review and meta-analysis. Clin Exp Pediatr. 2022 Jan;65(1):35-46.
 Centers for Disease Control and Prevention. Consequences of obesity. Last accessed: December 2022. Available at: https://www.cdc.gov/obesity/basics/consequences.html.
 World Health Organization. Obesity and overweight factsheet no. 311. Last accessed: December 2022. Available at: https://www.who.int/mediacentre/factsheets/fs311/en/.
 Cawley J, Meyerhoefer C, Biener A, et al. Savings in medical expenditures associated with reductions in body mass index among US adults with obesity, by Diabetes Status. Pharmacoeconomics. 2015;33:707–722.
 Centers for Disease Control and Prevention. Adult Obesity Facts. Last accessed: December 2022. Available at: https://www.cdc.gov/obesity/data/adult.html.