Press release

FDA approves once-weekly Wegovy^® injection for the treatment of obesity in teens aged 12 years and older

• New indication based on clinical trial that demonstrated a 16.1% reduction in body mass index (BMI) in teens with obesity treated with Wegovy^® (semaglutide) injection 2.4 mg compared to placebo (0.6% increase in BMI) ¹
• Approval represents a step forward in the management of teenage obesity, a chronic disease on the rise in the U.S. that can lead to serious weight-related health problems ^{2, 3}
• This is a label expansion for Wegovy^®, which received its first approval in 2021 in adults¹

 

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 95^th 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.

• Wegovy ^® should be used with a reduced calorie meal plan and increased physical activity
• Wegovy ^® contains semaglutide and should not be used with other semaglutide-containing products or other GLP-1 receptor agonist medicines
• It is not known if Wegovy ^® is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products
• It is not known if Wegovy ^® can be used safely in people with a history of pancreatitis
• It is not known if Wegovy ^® is safe and effective for use in children under 12 years of age

Important Safety Information

What is the most important information I should know about Wegovy^®?

Wegovy^® may cause serious side effects, including:

• Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, Wegovy ^® and medicines that work like Wegovy ^® caused thyroid tumors, including thyroid cancer. It is not known if Wegovy ^® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people

• Do not use Wegovy ^® if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

Do not use Wegovy^® if:

• you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• you have had a serious allergic reaction to semaglutide or any of the ingredients in Wegovy ^®

Before using Wegovy^®, tell your healthcare provider if you have any other medical conditions, including if you:

• have or have had problems with your pancreas or kidneys
• have type 2 diabetes and a history of diabetic retinopathy
• have or have had depression, suicidal thoughts, or mental health issues
• are pregnant or plan to become pregnant. Wegovy ^® may harm your unborn baby. You should stop using Wegovy ^® 2 months before you plan to become pregnant
• are breastfeeding or plan to breastfeed. It is not known if Wegovy ^® passes into your breast milk

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:

• inflammation of your pancreas (pancreatitis). Stop using Wegovy ^® and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back
• gallbladder problems. Wegovy ^® may cause gallbladder problems, including gallstones. Some gallstones may need surgery. Call your healthcare provider if you have symptoms, such as pain in your upper stomach (abdomen), fever, yellowing of the skin or eyes (jaundice), or clay-colored stools
• increased risk of low blood sugar (hypoglycemia) in patients with type 2 diabetes, especially those who also take medicines for type 2 diabetes such as sulfonylureas or insulin. This can be both a serious and common side effect. Talk to your healthcare provider about how to recognize and treat low blood sugar and check your blood sugar before you start and while you take Wegovy ^®. Signs and symptoms of low blood sugar may include dizziness or light-headedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, or feeling jittery
• kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration
• serious allergic reactions. Stop using Wegovy ^® and get medical help right away, if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat
• change in vision in people with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Wegovy ^®
• increased heart rate. Wegovy ^® can increase your heart rate while you are at rest. Tell your healthcare provider if you feel your heart racing or pounding in your chest and it lasts for several minutes
• depression or thoughts of suicide. You should pay attention to any mental changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you

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

About Wegovy^®

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

About obesity

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 .

Further information

Media:
Allison Schneider (US)
+1 732 513 4875
aocd@novonordisk.com

Investors:
Mark Joseph Root (US)
+1 848 213 3219
mjhr@novonordisk.com

 

Questions from non-U.S. media should be directed to MediaRelations@novonordisk.com.

 

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