Fri, 04 Jun 2021 15:46:00 -0400
PLAINSBORO, N.J., June 4, 2021 /PRNewswire/ -- Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved the new drug application (NDA) for Wegovy™ (semaglutide) injection 2.4 mg, the first-and-only prescription weight-loss medication with once-weekly dosing. Wegovy™ is used with a reduced calorie meal plan and increased physical activity for adults with obesity (BMI ≥30) or overweight (excess weight) (BMI ≥27) who also have weight related medical problems to help them lose weight and keep the weight off.1
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Approximately 42% of adults in the US live with obesity, a chronic disease which is recognized by the Centers for Disease Control and Prevention (CDC) as an epidemic.2,3 Obesity is a gateway disease associated with at least 60 other serious health conditions and decreased life expectancy.4,5
The FDA approval of Wegovy™ was based on the results of the STEP (Semaglutide Treatment Effect in People with Obesity) clinical trial program, which included four phase 3a clinical trials involving approximately 4,500 patients. The trials demonstrated that patients taking Wegovy™ with a reduced calorie meal plan and increased physical activity achieved a significant reduction in body weight compared with placebo (reduced calorie meal plan and increased physical activity only). In the STEP 1 trial, results also showed that patients taking Wegovy™ achieved an average weight loss of 14.9% of body weight at 68-weeks vs. 2.4% for placebo. In addition, 83.5% of patients achieved 5% or more body weight reduction in the Wegovy™ arm vs. 31.1% for placebo.1
The most frequently reported adverse events were nausea, diarrhea, vomiting, constipation, and abdominal pain.1
"This is the first time we have seen this magnitude of weight loss with a medicine. This approval gives people with obesity a once-weekly, non-surgical option with results that have never been demonstrated with an anti-obesity medicine before," said Dr. Robert Kushner, professor of medicine and medical education at Northwestern University, Feinberg School of Medicine, Chicago. "The approval of Wegovy™ represents a turning point for healthcare providers to embrace medical management of obesity to help improve chronic weight management for patients."
"For more than two decades, Novo Nordisk has led the charge to translate the complex science behind obesity into medicines that can make a difference, all while partnering across industries and sectors to change how obesity is understood, diagnosed and treated," said Doug Langa, executive vice president, North America operations and president of Novo Nordisk Inc. "With the unprecedented efficacy of Wegovy™ and our innovative, industry-leading pipeline, we have the most significant opportunity yet to drive meaningful change for people with obesity, and the providers committed to their health."
Obesity is recognized as a chronic disease and health issue by leading health organizations, including the American Medical Association, Centers for Disease Control and Prevention, The Obesity Society, and the World Obesity Federation, among other global organizations.3,6-8 Obesity has many contributing factors, including genetics, lifestyle and environment.9
"It's remarkable that obesity is still seen as a personal flaw rather than a medical condition requiring treatment, just like any other chronic disease. This disease can negatively impact one's quality of life, both through societal weight bias and stigma, as well as its association with numerous serious health issues," said Joe Nadglowski, president and chief executive officer of the Obesity Action Coalition. "It's time that we recognized this national public health crisis and the need for as many tools as possible to address it. Expanding safe and clinically effective treatment options for obesity management is good news for people with obesity and the medical community."
Novo Nordisk expects to launch Wegovy™ later this month. For further information, please visit www.Wegovy.com.
Wegovy™ Indication and Important Safety Information
What is Wegovy™?
Wegovy™ (semaglutide) injection 2.4 mg is an injectable prescription medicine used for adults with obesity (BMI ≥30) or overweight (excess weight) (BMI ≥27) 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:
Please see Prescribing Information including Medication Guide 1, 10
About the STEP clinical trial program
STEP (Semaglutide Treatment Effect in People with Obesity) is a phase 3 clinical development program with once-weekly subcutaneous semaglutide 2.4 mg in obesity. The global clinical phase 3a program consists of four trials and has enrolled approximately 4,500 adults with overweight or obesity.1
Wegovy™ is a GLP-1 receptor agonist.1 It is currently under review in the European Union and other countries.11
Obesity is a chronic, progressive and misunderstood disease that requires long term medical management.6 ,12,13 One key misunderstanding is that this is a disease of willpower, when in fact there is underlying biology that prevents people from losing weight and keeping it off.9 Obesity is influenced by a variety of factors, including genetics, appetite signals, behavior and the environment.9 It is a gateway disease and is associated with at least 60 other health conditions.4 The current COVID-19 pandemic has highlighted that obesity also increases the risk for severe illness and hospitalization due to COVID-19.14-17 The global increase in the prevalence of obesity is a public health issue that has severe cost implications to healthcare systems.18,19 In the United States, more than 42% of adults live with obesity.2
About Novo Nordisk
Novo Nordisk is a global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for 95 years. This heritage has given us experience and capabilities that also enable us to help people defeat other serious diseases including obesity, hemophilia and growth disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term and do business in a financially, socially and environmentally responsible way. With U.S. headquarters in New Jersey and production and research facilities in six states, Novo Nordisk employs nearly 6,000 people throughout the country. For more information, visit novonordisk.us, Facebook, Instagram and Twitter.
1 Wegovy™ (semaglutide) injection 2.4 mg Prescribing Information . Plainsboro, NJ: Novo Nordisk Inc.; 2021.
2 Adult Obesity Facts. Centers for Disease Control and Prevention. Available at: https://www.cdc.gov/obesity/data/adult.html. Updated February 11, 2021. Last Accessed: May 2021.
3 About Overweight and Obesity. Centers for Disease Control and Prevention. Available at: https://www.cdc.gov/obesity/about-obesity/index.html. Updated April 7, 2021. Last Accessed: May 2021.
4 Bays HE, McCarthy W, Christensen S, et al. Obesity Algorithm, presented by the Obesity Medicine Association. Available at: https://obesitymedicine.org/obesity-algorithm/. Last Accessed: May 2021.
5 Peeters A, Barendregt JJ, Willekens F, et al. Obesity in adulthood and its consequences for life expectancy: a life-table analysis. Ann Intern Med. 2003 Jan 7;138(1):24-32. doi: 10.7326/0003-4819-138-1-200301070-00008. PMID: 12513041.
6 American Medical Association. A.M.A Adopts New Policies on Second Day of Voting at Annual Meeting. Obesity as a Disease. Available at: https://news.cision.com/american-medical-association/r/ama-adopts-new-policies-on-second-day-of-voting-at-annual-meeting,c9430649. Last accessed: March 2021.
7 The Obesity Society. Obesity as a Disease: The Obesity Society 2018 Position Statement. Available at: https://www.obesity.org/wp-content/uploads/2019/04/Jastreboff_et_al-2019-Obesity.pdf. Last Accessed: May 2021.
8 World Obesity Federation. Obesity as a disease. Available at: https://www.worldobesity.org/what-we-do/our-policy-priorities/obesity-as-a-disease. Last Accessed: May 2021.
9 Wright SM, Aronne LJ. Causes of obesity. Abdom Imaging. 2021;37(5):730-732.
10 Wegovy™ (semaglutide) injection 2.4 mg Important Safety Information. Plainsboro, NJ: Novo Nordisk Inc.; 2021.
11 Novo Nordisk files for EU regulatory approval of once-weekly semaglutide 2.4 mg for weight management. Available at: https://www.novonordisk.com/news-and-media/news-and-ir-materials/news-details.html?id=39374. December 2020. Accessed May 2021.
12 Bray GA, Kim KK, Wilding JPH. World Obesity Federation. Obesity: a chronic relapsing progressive disease process. A position statement of the World Obesity Federation. ObesRev. 2017;18(7):715-723. doi:10.1111/obr.12551.
13 Puhl RM, Heuer CA. The stigma of obesity: a review and update. Obesity. 2009;17(5):941-964
14 Finer N, Garnett SP and Bruun JM. COVID-19 and obesity. Clin Obes. 2020; 10:e12365.
15 Ryan DH, Ravussin E and Heymsfield S. COVID 19 and the Patient with Obesity - The Editors Speak Out. Obesity ( Silver Spring ). 2020; 28:847.
16 Body Mass Index and Risk for COVID-19–Related Hospitalization, Intensive Care Unit Admission, Invasive Mechanical Ventilation, and Death - United States, March–December 2020. Centers for Disease Control and Prevention. https://www.cdc.gov/mmwr/volumes/70/wr/mm7010e4.htm?s_cid=mm7010e4_w. Updated March 8, 2021. Last Accessed: March 10, 2021.
17 Obesity, Race/Ethnicity, and COVID-19. Centers for Disease Control and Prevention. https://www.cdc.gov/obesity/data/obesity-and-covid-19.html. Updated March 22, 2021. Last Accessed: May 2021.
18 World Health Organization. Obesity and Overweight Factsheet no. 311. Available at: http://www.who.int/mediacentre/factsheets/fs311/en/. Last accessed: May 2021.
19 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.
SOURCE Novo Nordisk