Novo Nordisk has announced today that the US Food and Drug Administration (FDA) has granted approval for an expanded label for Wegovy®. This approval, based on a supplemental New Drug Application (sNDA), extends the indication of Wegovy® to include the reduction of risks associated with major adverse cardiovascular events (MACE) in adults suffering from either overweight or obesity and established cardiovascular disease (CVD).
The approval stems from the findings of the SELECT cardiovascular outcomes trial. In this trial, Wegovy® exhibited a statistically significant reduction of 20% in the risk of MACE compared to placebo when added to standard care. Though the exact mechanism of cardiovascular risk reduction remains to be fully established, the SELECT trial demonstrated consistent risk reductions in MACE over a period of up to five years, irrespective of various baseline factors such as age, sex, race, ethnicity, body mass index (BMI), and renal function impairment.
Moreover, the label update includes data from SELECT indicating a 15% reduction in cardiovascular death risk and a 19% reduction in overall mortality compared to placebo. Additional clinical data from the SELECT trial have also been incorporated into the label.
Martin Holst Lange, Executive Vice President and Head of Development at Novo Nordisk, expressed satisfaction with the approval, highlighting its significance for individuals managing obesity and cardiovascular disease. He emphasized Wegovy®’s potential to prolong lives by addressing leading causes of preventable deaths through the reduction of cardiovascular events.
Novo Nordisk has also submitted for a label expansion in the EU, with a decision anticipated in 2024.
Obesity is recognized as a chronic disease necessitating long-term management due to its association with various serious health complications and reduced life expectancy. These complications include type 2 diabetes, chronic kidney disease, non-alcoholic fatty liver disease, cancer, and an elevated risk of cardiovascular diseases such as heart attack and stroke, along with high levels of blood sugar, cholesterol, blood pressure, and inflammation.
The SELECT trial was a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy of semaglutide 2.4 mg in preventing MACE in individuals with established CVD and either overweight or obesity, without a prior history of diabetes. The trial, conducted over five years, involved 17,604 adults across 41 countries and over 800 investigator sites.
SELECT data were presented at the American Heart Association (AHA) annual meeting in November 2023 and published in the New England Journal of Medicine (NEJM).
With the US label update, Wegovy® is now indicated for use alongside a reduced calorie diet and increased physical activity to mitigate MACE risks in adults with established cardiovascular disease and either obesity or overweight. Additionally, it aims to facilitate weight loss and maintain long-term weight reduction in adults and pediatric patients aged 12 years and older with obesity, as well as in adults with overweight and at least one weight-related comorbid condition.
Wegovy® has already been introduced in several countries, including Denmark, Norway, Germany, the UK, Iceland, Switzerland, UAE, and Japan. In these regions, it is recommended as an adjunct to dietary adjustments and increased physical activity for chronic weight management in adults with obesity (BMI ≥ 30 kg/m2), overweight individuals (BMI ≥ 27 kg/m2) with at least one weight-related comorbid condition, and, in specific regions, for pediatric patients aged 12 years and older with obesity.
