Wegovy® Approved in the US for Mitigating Cardiovascular Risks Among Individuals with Overweight or Obesity and Established Cardiovascular Disease
Saturday, March 09, 2024
Novo Nordisk announced today that the US Food and Drug Administration (FDA) has approved a label expansion for Wegovy® based on a supplemental New Drug Application (sNDA). This expansion now includes the indication for reducing the risks of major adverse cardiovascular events (MACE), such as cardiovascular death, non-fatal heart attack (myocardial infarction), or non-fatal stroke, in adults with overweight or obesity and established cardiovascular disease (CVD).
The approval stems from the SELECT cardiovascular outcomes trial, demonstrating that Wegovy® effectively decreased the risk of MACE by 20% compared to placebo when combined with standard care. While the precise mechanism for cardiovascular risk reduction remains undetermined, findings from SELECT indicate consistent risk reductions in MACE over a five-year period across various demographics, including age, sex, race, ethnicity, BMI, and renal function impairment levels. Moreover, the label now includes data indicating a 15% reduction in cardiovascular death and a 19% reduction in all-cause mortality compared to placebo. Additional clinical insights from SELECT have also been integrated into the label.
Martin Holst Lange, Novo Nordisk's Executive Vice President and Head of Development, expressed satisfaction with the approval, emphasizing its significance for individuals managing obesity and cardiovascular disease. Lange highlighted Wegovy®'s potential to prolong lives by mitigating leading causes of preventable deaths through the reduction of cardiovascular events.
Furthermore, Novo Nordisk has submitted for a label expansion in the EU, with a decision anticipated in 2024.
Obesity is a chronic condition associated with numerous severe health complications, including type 2 diabetes, chronic kidney disease, non-alcoholic fatty liver disease, cancer, and an elevated risk of CVD, encompassing heart attacks and strokes, as well as elevated levels of blood sugar, cholesterol, blood pressure, and inflammation.
The SELECT trial, a randomized, double-blind, placebo-controlled study, evaluated the efficacy of semaglutide 2.4 mg in reducing MACE incidence over five years among individuals with established CVD, overweight, or obesity without prior diabetes history. Key secondary objectives included assessing mortality, heart failure, cardiovascular risk factors, body weight, and kidney function. The trial enrolled 17,604 adults across 41 countries and over 800 investigator sites, with initiation in 2018. 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).
Wegovy® (semaglutide 2.4 mg) is now indicated in the US, in combination with a reduced-calorie diet and increased physical activity, for reducing the risk of MACE in adults with established cardiovascular disease and either obesity or overweight. Additionally, it aids in weight reduction and long-term maintenance for adults and pediatric patients aged 12 years and older with obesity, as well as for adults with overweight and at least one weight-related comorbid condition.
Source: globenewswire.com
