MISSISSAUGA, ON, Nov. 25, 2021 /CNW/ - Novo Nordisk announced today that Health Canada has approved Wegovy™ (semaglutide injection), the first-and-only prescription weight-loss medication with once-weekly dosing. Wegovy™ is indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obesity), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbidity such as hypertension, type 2 diabetes mellitus, dyslipidemia, or obstructive sleep apnea.1 Wegovy™ is expected to be commercially available in Canada in the fall of 2022.
Approximately 8.3 million adults in Canada live with obesity2, a chronic disease which is recognized by leading health organizations including Obesity Canada, the Canadian Medical Association, and World Obesity Federation, among other global organizations.2 Obesity is a disease associated with at least 60 other serious health conditions and decreased life expectancy.3,4
About Obesity
Obesity is a chronic condition that is associated with serious comorbidities including hypertension, type 2 diabetes mellitus, dyslipidemia, certain types of cancer and a decreased life expectancy. The risk of morbidity and mortality increases with the severity of obesity. It is a complex and multi-factorial disease that is influenced by genetic, physiological, environmental and psychological factors.5 Just like other chronic diseases, obesity requires long-term management.6
The global increase in the prevalence of obesity is a public health issue that has severe cost implications to healthcare systems. Today, in Canada, an estimated 30 per cent, or more than one in four adults, are living with obesity and may require medical support to manage their disease.7
About STEP
The efficacy and safety of Wegovy™ is supported by data from the STEP (Semaglutide Treatment Effect in People with Obesity) clinical trial program. STEP 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 pivotal trials and has enrolled approximately 4,500 adults with overweight or obesity.1
The trials investigated Wegovy™ compared with placebo, both in addition to a reduced calorie diet and increased physical activity as a means of achieving a reduction in body weight. In the STEP trials, the primary outcome measure was the change in body weight of randomized patients from baseline (week 0) to week 68.
In the largest phase 3a trial, STEP 1, results showed that patients taking Wegovy™ achieved a mean weight loss of 15 per cent – 17 per cent (16kg – 19 kg) sustained over 68 weeks.1 In addition, 83.5 per cent of patients achieved 5 per cent or more body weight reduction in the Wegovy™ arm vs. 31.1 per cent for placebo.1
Participants who received Wegovy™ also had clinically meaningful improvements in physical function and treatment benefits were observed in the secondary endpoints including waist circumference and cardiometabolic parameters".1 The most frequently reported adverse events were nausea, diarrhea, vomiting, constipation, abdominal pain, headache and fatigue.1
About Wegovy™
Wegovy™ is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obesity), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbidity such as hypertension, type 2 diabetes mellitus, dyslipidemia, or obstructive sleep apnea.1
Wegovy™ is currently approved in Canada the United States and the United Kingdom and is under review in the European Union and other countries.
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 42,700 people in 80 countries and markets its products in approximately 170 countries.
For more information, visit novonordisk.ca, or @NovoNordiskCA on Twitter.
1 Wegovy™ (semaglutide injection), Novo Nordisk Canada Inc., Product Monograph, November 2021 |
2 Twells LK, Janssen I, Kuk JL. Canadian Adult Obesity Clinical Practice Guidelines: Epidemiology of Adult Obesity. Accessed August 2021. Available at: https://obesitycanada.ca/guidelines/epidemiology. |
3 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. |
4 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. |
5 Multimorbidity in a prospective cohort: Prevalence and associations with weight loss and health status in severely obese patients. Obesity (Silver Spring). 2015 Mar;23(3):707-12. doi: 10.1002/oby.21008. Epub 2015 Feb 13. |
6 Wharton et al. Obesity in adults: a clinical practice guideline. CMAJ. 2021 August 4; 192:E875-91. doi: 10.1503/cmaj.191707. Available at: https://www.cmaj.ca/content/cmaj/192/31/E875.full.pdf |
7 Health Fact Sheets: Overweight and obese adults, 2018. Overweight and obese adults, 2018 (statcan.gc.ca). June 25, 2019 |
SOURCE Novo Nordisk
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
