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.
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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.
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