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FDA Approves Wegovy to Reduce Heart Disease and Stroke Risk in People With Obesity

The FDA has now approved Wegovy to reduce cardiovascular risk in people with obesity, in a label expansion based on results from Novo Nordisk’s SELECT trial.

Excess weight raises the risk for type 2 diabetes, heart attacks, and stroke. Now people who are at higher risk for cardiovascular events such as a heart attack or stroke have another resource to add to their treatment toolbox: Wegovy.

The U.S. Food and Drug Administration (FDA) expanded the label for the use of Wegovy (semaglutide) to include reducing cardiovascular risk, making Wegovy the first medication to reduce heart disease and stroke in people with overweight or obesity without diabetes.

The label expansion specifically highlights the use of Wegovy to reduce risks of major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal heart attack (myocardial infarction), 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, in a statement.

“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.”

Novo Nordisk has also filed for a label expansion in the EU, with a decision also expected in 2024.

Why did the FDA expand the use of Wegovy to include cardiovascular risk reduction?

FDA Approves Wegovy for Heart Disease RiskThe FDA’s label expansion follows results of a clinical trial that showed Wegovy can significantly reduce weight plus lower the chance of cardiovascular events by 20%.

The SELECT clinical trial included over 17,600 adults aged 45 years and older with overweight or obesity and a prior history of heart disease and who did not have diabetes. It was the first study of its kind to show the heart health benefits of Wegovy for people with obesity or overweight without diabetes.

After five years, participants taking 2.4 mg of semaglutide saw a 20% reduction in heart attacks, stroke, and heart-related deaths. These impressive cardiovascular benefits occurred regardless of adherence, or how consistently participants took Wegovy.

Wegovy was well-tolerated and side effects results were similar to those reported in previous trials of the drug. Similar to other GLP-1 receptor agonist and incretin medications, nausea, vomiting, and other gastrointestinal issues are the most common side effects of Wegovy.

In light of the FDA’s ruling, Wegovy’s label will be updated to include data from SELECT showing a risk reduction in cardiovascular death by 15% and a risk reduction of death from any cause by 19%, both compared to placebo.

What did Novo Nordisk’s SELECT trial demonstrate for Wegovy in people with overweight or obesity?

A Wegovy injection penFindings from the SELECT trial suggested that Wegovy has the potential to transform care for people with overweight and obesity who also have heart disease; in addition to being effective for weight loss, Wegovy was also able to help reduce the risk of cardiovascular problems, which are common among those living with conditions like obesity and diabetes.

“A 20% reduction in major adverse cardiovascular events is a large, clinically meaningful benefit,” said Dr. Mikhail Kosiborod, director of Cardiometabolic Research in Saint Luke’s Michael and Marlys Haverty Cardiometabolic Center of Excellence.

“Together with other data emerging in cardiometabolic space, this will change the conversation about the role of obesity in individuals with cardiovascular disease – from a ‘comorbidity’ to a root cause and an intervention target,” he said.

The SELECT results are especially impressive compared to the Look AHEAD trial, which studied the impacts of intensive lifestyle changes such as a calorie-restricted diet and exercise on weight loss and heart health. After nearly 10 years, Look AHEAD was stopped due to the lack of heart benefit. Meanwhile, SELECT demonstrated the benefit of this weight loss medication on heart disease in people with obesity or overweight without diabetes. This finding suggests a new path forward for obesity management and the prevention of heart complications.

Wegovy is a GLP-1 agonist, which works by mimicking hormones that the body naturally produces to stimulate the release of insulin after a meal.

The SELECT findings are the latest in a series of victories for Wegovy and other versions of semaglutide. Similar results of heart benefit were previously seen for the injectable version of semaglutide in people with type 2 diabetes.

Combined results from the SUSTAIN 6 and PIONEER 6 trials showed a 24% reduction in heart attack, stroke, and heart-related deaths. Ozempic previously received FDA approval for cardiovascular health in people with type 2 diabetes. The success of the SELECT trial may lead to a similar approval for Wegovy in people with obesity or overweight.

Results from the PIONEER PLUS and OASIS trials showed that Rybelsus, an oral version of semaglutide, is effective for treating type 2 diabetes and overweight or obesity at high doses.

Additional reporting by Susannah Chen

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Photo credits: Novo Nordisk (Wegovy); iStock (all other photos).