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FDA Approves Wegovy as First Treatment to Reduce Risk of Heart Problems in Obese Adults

The FDA has approved Wegovy® for reducing cardiovascular risks in adults with obesity or overweight and known heart disease. Based on the SELECT trial, Wegovy® demonstrated a 20% reduction in major adverse cardiovascular events (MACE) compared to placebo. This approval marks a significant advancement in offering a dual benefit of weight management and cardiovascular risk reduction, addressing critical health issues.

The U.S. Food and Drug Administration (FDA) has expanded the use of Wegovy® (semaglutide 2.4 mg), making it the first medicine approved for both the reduction of major adverse cardiovascular events (MACE) such as heart attack, stroke, or cardiovascular death, and for long-term weight management in adults with known heart disease who are overweight or obese.

The approval is based on the results from the SELECT trial, the largest cardiovascular outcomes study conducted among individuals with obesity and known heart disease, which demonstrated a significant reduction in the risk of MACE by 20% compared to placebo when Wegovy® was added to standard cardiovascular care.

"Wegovy is now the first weight loss medication to also be approved to help prevent life-threatening cardiovascular events in adults with cardiovascular disease and either obesity or overweight. This patient population has a higher risk of cardiovascular death, heart attack and stroke. Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health," said Dr. John Sharretts, Director of the Division of Diabetes, LD and Obesity in the FDA's Center for Drug Evaluation and Research.

The SELECT trial, initiated in 2018, involved 17,604 adults across 41 countries, focusing on the efficacy of semaglutide 2.4 mg in preventing cardiovascular events in people with established cardiovascular disease (CVD) and obesity or overweight, without previous diabetes history. The trial found notable reductions in the risk of cardiovascular death by 15% and death from any cause by 19%, regardless of the patient's age, sex, race, ethnicity, body mass index (BMI), or level of renal function impairment.

"This approval is a significant decision because people living with excess weight or obesity and established cardiovascular disease and without diabetes have never had an FDA-approved treatment option that lowers weight and reduces the likelihood of another cardiovascular event. For healthcare professionals, this approval provides a new treatment option to help us address cardiovascular residual risk that remains for patients on current standard of care." said Dr. A. Michael Lincoff, Professor of Medicine at Cleveland Clinic and the lead study author of the SELECT outcomes trial.

Wegovy® is now indicated in combination with a reduced calorie diet and increased physical activity for the reduction of MACE in adults with established cardiovascular disease and either obesity or overweight. It is also approved for chronic weight management 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 comorbidity.

Martin Holst Lange, EVP and Head of Development at Novo Nordisk, expressed great satisfaction with the FDA's approval, highlighting its pioneering role in aiding individuals in weight management and diminishing cardiovascular risks. He emphasized, “This approval is an important milestone for people living with obesity and cardiovascular disease, as the SELECT data demonstrated that Wegovy® has the potential to prolong lives by addressing some of the leading causes of preventable deaths by reducing the risks of cardiovascular events.”

With obesity-related cardiovascular disease deaths having tripled in the U.S. between 1999 and 2020, the approval of Wegovy® represents a significant advancement in the fight against obesity and cardiovascular disease, two of the most pressing health issues facing the nation today. Novo Nordisk has also filed for a label expansion in the EU, with a decision expected in 2024, potentially making Wegovy® a global option for those at risk of cardiovascular events due to obesity and known heart disease.

About the SELECT trial

The SELECT trial, a randomized, placebo-controlled study, assessed semaglutide 2.4 mg's effectiveness in reducing major adverse cardiovascular events (MACE) in individuals over 45 years old with established cardiovascular disease (CVD), overweight, or obesity, but no diabetes, over five years. Aimed to prove semaglutide's superiority over placebo in preventing cardiovascular death, heart attacks, or strokes, it also evaluated its impact on mortality, heart failure, and cardiovascular risk factors. The trial included 17,604 participants across 41 countries and over 800 sites, starting in 2018, with results shared at the AHA meeting in 2023 and published in the NEJM.

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About Author: Hüseyin Kandemir

As a medical journalist with over 20 years of experience, I have served as an Editor and Reporter for various magazines, newspapers, and online broadcasting platforms, consistently demonstrating a strong commitment to excellence in journalism. My specialization includes medical science, digital health, AI for health, data science, and biotechnology.

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