The FDA has approved Wegovy to reduce cardiovascular risk in people with obesity, based on results from Novo Nordisk’s SELECT trial.
Excess weight raises the risk of Type 2 diabetes, heart attacks, and stroke, but the SELECT clinical trial has shown that showed Wegovy (semaglutide) can significantly reduce weight and lower the chance of cardiovascular events by 20%.
The survey included over 17,600 adults aged 45 years and older with overweight or obesity and a prior history of heart disease but who did not have diabetes. It found that, over five years, participants taking 2.4 mg of semaglutide saw a 20% reduction in heart attacks, stroke, and heart-related deaths, regardless of adherence, or how consistently participants took Wegovy.
The FDA ruling highlights the use of Wegovy to reduce risks of major adverse cardiovascular events, including cardiovascular death, non-fatal heart attack, or non-fatal stroke in adults with either overweight or obesity and established cardiovascular disease. “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,” said Dr. John Sharretts, director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research.
Novo Nordisk has also filed for a label expansion in the EU, with a decision also expected in 2024.
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