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March 15, 2024

The FDA Approves Wegovy® To Help Prevent Life-Threatening Cardiovascular Events

Written By
Medically Reviewed by
Updated On
September 17, 2024

The U.S. Food and Drug Administration (FDA) approved the use of Novo Nordisk’s drug Wegovy® to reduce the risk of heart-related complications in adults with cardiovascular disease and obesity.

According to a statement from the agency: 

“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.” 

We’ll explore the potential implications of this approval in this article.

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What is Wegovy? 

Wegovy® is part of a class of medications called GLP-1 drugs — which stands for glucagon-like peptide-1 receptor agonists — that help manage blood sugar levels in people with Type 2 diabetes

Wegovy®, along with other GLP-1 drugs, has been increasingly used for weight loss purposes. Research supports this use case, with a recent study in The Lancet finding that a combination of GLP-1 drugs and exercise is the most effective treatment for long-term weight management. 

However, this is the first time that a weight loss medication has also been approved to help reduce the risk of cardiovascular complications. 

This decision came as a result of a multi-national, multi-center, placebo-controlled double-blind drug trial called SELECT that was designed to test Wegovy®’s efficacy and safety for this new indication. 

Over 17,600 participants were randomly assigned to receive either Wegovy® or a placebo, along with standard-of-care medical treatment (e.g., management of blood pressure and cholesterol) and healthy lifestyle counseling (including diet and physical activity). 

The results showed that Wegovy® significantly reduced the risk of cardiovascular death, heart attack and stroke — with these complications occurring only in 6.5% of participants who received the drug, compared to 8% of participants who received the placebo.

The implications of this news

Approving this new indication for Wegovy® could potentially expand insurance coverage for this drug, which currently costs more than $1,300 per dose. 

With more employers threatening to discontinue coverage of weight-loss drugs, the FDA’s decision could be critical in terms of making this medication more financially accessible for patients.

Between the European Union considering approving Wegovy® for the same indication and its recent rollout in Asia, it’s clear that there will be more developments to come with this GLP-1 drug. 

[signup]

Key Takeaways

  • The FDA has approved the use of Wegovy® to reduce the risk of heart-related complications in adults with cardiovascular disease and obesity.
  • The results of a drug trial found that the drug significantly reduced the risk of cardiovascular death, heart attack, and stroke.
  • This approval may lead to expanded insurance coverage.

The U.S. Food and Drug Administration (FDA) approved the use of Novo Nordisk’s drug Wegovy® to help reduce the risk of heart-related complications in adults with cardiovascular disease and obesity.

According to a statement from the agency: 

“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.” 

We’ll explore the potential implications of this approval in this article.

[signup]

What is Wegovy? 

Wegovy® is part of a class of medications called GLP-1 drugs — which stands for glucagon-like peptide-1 receptor agonists — that help manage blood sugar levels in people with Type 2 diabetes

Wegovy®, along with other GLP-1 drugs, has been increasingly used for weight management purposes. Research supports this use case, with a recent study in The Lancet finding that a combination of GLP-1 drugs and exercise may be effective for long-term weight management. 

However, this is the first time that a weight management medication has also been approved to help reduce the risk of cardiovascular complications. 

This decision came as a result of a multi-national, multi-center, placebo-controlled double-blind drug trial called SELECT that was designed to test Wegovy®’s efficacy and safety for this new indication. 

Over 17,600 participants were randomly assigned to receive either Wegovy® or a placebo, along with standard-of-care medical treatment (e.g., management of blood pressure and cholesterol) and healthy lifestyle counseling (including diet and physical activity). 

The results showed that Wegovy® significantly reduced the risk of cardiovascular death, heart attack and stroke — with these complications occurring only in 6.5% of participants who received the drug, compared to 8% of participants who received the placebo.

The implications of this news

Approving this new indication for Wegovy® could potentially expand insurance coverage for this drug, which currently costs more than $1,300 per dose. 

With more employers considering discontinuing coverage of weight-management drugs, the FDA’s decision could be critical in terms of making this medication more financially accessible for patients.

Between the European Union considering approving Wegovy® for the same indication and its recent rollout in Asia, it’s clear that there will be more developments to come with this GLP-1 drug. 

[signup]

Key Takeaways

  • The FDA has approved the use of Wegovy® to help reduce the risk of heart-related complications in adults with cardiovascular disease and obesity.
  • The results of a drug trial found that the drug significantly reduced the risk of cardiovascular death, heart attack, and stroke.
  • This approval may lead to expanded insurance coverage.
The information in this article is designed for educational purposes only and is not intended to be a substitute for informed medical advice or care. This information should not be used to diagnose or treat any health problems or illnesses without consulting a doctor. Consult with a health care practitioner before relying on any information in this article or on this website.

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