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FDA approves Wegovy for reducing heart problems in adults with obesity

This expanded approval provides a new indication for the popular weight loss medication
Jennifer Larson writer headshot
By | Mar. 14, 2024 Medically reviewed by Karen Berger, Pharm.D.
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Key takeaways

  • The FDA approved a new indication for Wegovy (semaglutide), a popular weight-loss medication, to reduce the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease (CVD) and obesity or overweight.

  • The newly approved use of Wegovy should be done in conjunction with a diet and exercise to help people living with CVD.

  • The manufacturer, Novo Nordisk, has not released any additional information about how the approval will affect the ongoing shortage of the medication. 

In this article:

First approved by the U.S. Food and Drug Administration (FDA) in 2021, more people may be eligible to take the popular weight loss drug Wegovy (semaglutide) thanks to a recent expanded use approval.

On Mar. 8, the FDA announced that it had approved a new indication for the injectable medication: reducing the risk of cardiovascular death, heart attack, and stroke in adults who are either obese or overweight and have 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,” John Sharretts, MD, director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, said 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.”

According to manufacturer Novo Nordisk, the medication should be used in tandem with a reduced-calorie diet and increased physical activity.

Wegovy heart benefits

According to the FDA, about 70% of adults in the United States are either overweight or obese, which raises the risk for a number of serious medical conditions, including heart disease and even premature death. 

Also, cardiovascular disease is the leading cause of death for both men and women in the United States, according to the Centers for Disease Control and Prevention (CDC).

“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,” Martin Holst Lange, executive vice president and head of Development at Novo Nordisk, said in a statement referring to the results of the large randomized, double-blind, placebo-controlled trial that was published in the New England Journal of Medicine in December 2023.

The SELECT trial was a five-year trial that compared the efficacy of a weekly dose of semaglutide 2.4 mg with a placebo (inactive medicine) as an adjunct to the standard of care for the prevention of major adverse cardiovascular events (MACE) in overweight or obese people with established cardiovascular disease with no prior history of diabetes. 

How Wegovy works

The active ingredient in Wegovy is semaglutide. Wegovy belongs to the class of medications known as glucagon-like peptide-1 (GLP-1) receptor agonists. It acts like the GLP-1 hormone, which works in your brain to reduce your appetite, which usually reduces the amount of calories that you consume. 

This expanded approval for Wegovy was based on the results of the SELECT cardiovascular outcomes trial, which showed that Wegovy reduced the risk of MACE by 20% when compared with placebo. The FDA noted that the outcomes were achieved regardless of factors such as age, sex, race, ethnicity, and body mass index (BMI). 

However, the manufacturer noted that the exact mechanism by which Wegovy reduces cardiovascular risk has not yet been established. 

Alternatives to Wegovy for heart patients

Two other FDA-approved medications also contain semaglutide: Ozempic injections and Rybelsus tablets. Unlike Wegovy, which was approved specifically for weight loss in 2021, Ozempic and Rybelsus were approved to help people with diabetes lower their blood sugar levels, along with diet and exercise, with weight loss as a common side effect. 

Ozempic is already in use for helping people at risk for heart disease. Based on clinical trial results, the FDA approved an expanded use of Ozempic in 2020 for reducing the risk of major adverse cardiovascular events (MACE), which includes heart attack, stroke, or death in adults with Type 2 diabetes and known heart disease. At this time, Rybelsus does not have an FDA approval for lowering cardiovascular risk. 

How will the expanded approval affect the supply of Wegovy?

Wegovy has been on the FDA’s list of drug shortages since March 2022, stymying many people’s attempts to begin (or continue) taking the drug. Novo Nordisk announced in late January 2024 that it would soon be more than doubling the amount of the lower-strength dosages of Wegovy “while gradually increasing overall supply throughout the rest of the year.” 

However, the manufacturer has not released any additional information about the Wegovy supply since the FDA’s announcement about the expanded use for Wegovy.