Novo Nordisk has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion on updating the Wegovy® (semaglutide 2.4 mg) label. This update reflects data from the SELECT cardiovascular outcomes trial, showing a reduction in major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal heart attack, or non-fatal stroke, in adults with established cardiovascular disease (CVD) and either overweight or obesity (BMI ≥27 kg/m2) without diabetes.
The SELECT trial demonstrated a 20% reduction in MACE risk with Wegovy® compared to placebo when added to standard care. This risk reduction was consistent across various demographic and clinical groups, including different ages, sexes, races, BMIs, and levels of renal function impairment. The exact mechanism behind this cardiovascular risk reduction is not fully understood but is believed to be multifactorial.
Martin Holst Lange, executive vice president and head of Development at Novo Nordisk, stated, “The recommendation to update the EMA label for Wegovy® is a significant milestone for those living with cardiovascular disease and obesity. The SELECT data showed that, in addition to weight management, Wegovy® can potentially reduce the risks of major adverse cardiovascular events.”
The label update also includes data from the SELECT trial indicating a 15% reduction in cardiovascular death, a 19% reduction in death from any cause, and an 18% reduction in a composite endpoint of heart failure, including cardiovascular death, urgent heart failure visits, and hospitalizations for heart failure, compared to placebo.
Novo Nordisk expects the label update to be implemented within approximately one month, following the CHMP’s positive opinion.
About Obesity and Cardiovascular Disease
Obesity is a chronic condition that requires long-term management and is linked to numerous serious health issues and reduced life expectancy. Complications include type 2 diabetes, chronic kidney disease, non-alcoholic fatty liver disease, cancer, and an increased risk of cardiovascular disease, such as heart attack and stroke, along with high levels of blood sugar, cholesterol, blood pressure, and inflammation.
About the SELECT Trial
SELECT was a randomized, double-blind, parallel-group, placebo-controlled trial designed to evaluate the efficacy of Wegovy® versus placebo in preventing MACE in people with established CVD and either overweight or obesity, without a prior history of diabetes. The trial included participants aged 45 and older with a BMI of 27 kg/m2 or greater and followed them for up to five years.
The primary goal was to demonstrate the superiority of Wegovy® over placebo in reducing the incidence of three-point MACE (cardiovascular death, non-fatal heart attack, or non-fatal stroke). Secondary objectives included assessing the effects on mortality, heart failure, cardiovascular risk factors, glucose metabolism, body weight, and kidney function. The trial enrolled 17,604 adults and was conducted in 41 countries across more than 800 investigator sites. It began in 2018 and concluded in 2023.
About Wegovy® (Semaglutide 2.4 mg)
In the EU, Wegovy® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adults with a BMI of 30 kg/m2 or greater (obesity), or adults with a BMI of 27 kg/m2 or greater (overweight) with at least one weight-related comorbid condition. It is also indicated for pediatric patients aged 12 years and older with a BMI at the 95th percentile or greater for age and gender (obesity) and a body weight above 60 kg.
In the US, Wegovy® is indicated in combination with a reduced-calorie diet and increased physical activity to reduce the risk of MACE in adults with established cardiovascular disease and either obesity or overweight. It is also used to reduce excess body weight and maintain weight reduction long-term in adults and pediatric patients aged 12 years and older with obesity and in adults with overweight in the presence of at least one weight-related comorbid condition.
