Company statement

Sat, 11 Nov 2023 08:30:00 -0500

Sat, 11 Nov 2023 08:30:00 -0500

Wegovy® (semaglutide) injection 2.4 mg cardiovascular outcomes data presented at the American Heart Association Scientific Sessions and simultaneously published in the New England Journal of Medicine

PLAINSBORO, N.J., November 11, 2023 – Novo Nordisk today announced the full results of SELECT, its landmark phase 3 cardiovascular outcomes trial investigating the effects of onceweekly Wegovy® (semaglutide) injection 2.4 mg in adults with established cardiovascular disease (CVD) and overweight or obesity but without diabetes, at the American Heart Association (AHA) annual Scientific Sessions in Philadelphia and simultaneously published in the New England Journal of Medicine (NEJM).

SELECT is the largest trial conducted in Novo Nordisk history with more than 800 investigator sites and 17,604 participants in 41 countries and builds on more than 20 years of research in obesity.1 Obesity is one of the leading factors contributing to premature death from CVD in people living with obesity,2,3 yet it continues to be a misunderstood, underdiagnosed, and undertreated chronic disease.4,5

“Obesity is one of the most pressing societal, human and health issues of our time, affecting many of our loved ones, friends, and families. For people living with excess weight or obesity, a cardiovascular outcomes trial of this size has never been completed. With this community’s increased prevalence of cardiovascular disease, the SELECT data is an important step to better understanding obesity, while furthering our commitment to driving change in how this disease is seen and treated,” said Anna Windle, PhD, Senior Vice President, NAO Clinical Development, Medical & Regulatory Affairs at Novo Nordisk Inc. “We look forward to working with regulatory authorities on next steps based on the findings.”

Novo Nordisk has filed for a label update of Wegovy® in the US and EU to include an indication for reducing the risk of major adverse cardiovascular events (cardiovascular death, non-fatal heart attack or non-fatal stroke) in people with an initial BMI of 27 kg/m2 or greater and established cardiovascular disease (CVD). A decision is expected in 2024. The FDA has granted priority review for the supplemental New Drug Application.

SELECT (Semaglutide Effects on Cardiovascular Outcomes in People with Overweight or Obesity) was a multicenter, randomized, double blind, placebo-controlled, event-driven superiority trial designed to evaluate the efficacy of semaglutide 2.4 mg versus placebo as an adjunct to cardiovascular standard of care for reducing the risk of major adverse cardiovascular events in people with established CVD with overweight or obesity with no prior history of diabetes.1

People included in the trial were aged ≥45 years with a BMI ≥27 kg/m2. Baseline demographics by age group show that approximately 24% were aged 45-54, 38% aged 55-64, 30% aged 65-74, and 8% aged 75 years plus. By race or ethnicity, 84% of trial participants were white, 10% Hispanic or Latino, 8% Asian, 4% Black and 3% other. The split between male and female participants was 72% and 28%, respectively.1

The trial enrolled 17,604 adults and has been conducted in 41 countries at more than 800 investigator sites. The SELECT trial was initiated in 2018.1

About Wegovy® (semaglutide) injection 2.4 mg
Wegovy® (semaglutide) injection 2.4 mg is a GLP-1 receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adults with an initial BMI of 30 kg/m2 or greater (obesity), adults with an initial BMI of 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition, and pediatric patients aged 12 years and older with an initial BMI at the 95th percentile or greater for age and sex (obesity).6 Wegovy® is launched in the US, Denmark, Norway, Germany, UK, and Iceland.

About obesity
Obesity is a serious chronic, progressive, and misunderstood disease that requires long-term management.4,7,8 One key misunderstanding is that this is a disease of willpower, when in fact there is underlying biology that impedes people with obesity from losing weight and keeping it off.4,8 Obesity is influenced by a variety of factors, including genetics, social determinants of health, and the environment.9 Obesity is associated with weight-related problems, including high blood pressure, high cholesterol, and type 2 diabetes.10 The global increase in the prevalence of overweight and obesity is a public health issue that has severe cost implications to healthcare systems.11 In the United States, about 42% of adults live with obesity, and one out of five adolescents between the ages of 12-19 live with obesity.12,13

About Novo Nordisk
Novo Nordisk is a leading global healthcare company that has been making innovative medicines to help people with diabetes lead longer, healthier lives for 100 years. This heritage has given us experience and capabilities that also enable us to drive change to help people defeat other serious chronic diseases such as obesity and rare blood and endocrine 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 seven states, Novo Nordisk employs nearly 6,000 people
throughout the country. For more information, visit, Facebook, Instagram, and Twitter.

Novo Nordisk is committed to the responsible use of our semaglutide-containing medicines which represent distinct products with different indications, dosages, prescribing information, titration/dose-escalation schedules, and delivery forms. These products are not interchangeable
and should not be used outside of their approved indications.