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March 15, 2024

FDA Approves New Wegovy Indication to Prevent Life-Threatening Cardiovascular Events

On March 8, 2024, the U.S. Food and Drug Administration (“FDA”) approved a new indication for the use of Wegovy, a popular weight loss medication. More specifically, Wegovy injections can now be used to reduce the risk of heart attack and stroke in obese or overweight adults with cardiovascular disease. According to a company announcement by drugmaker Novo Nordisk, Wegovy has now been “approved in the US as the first therapy to help people manage their weight and reduce cardiovascular risks[.]” Given that the drug received priority review for this designation, its approval for this indication suggests that the FDA expects Wegovy to vastly enhance the safety and efficacy involved with preventing adverse cardiovascular events.

Pursuant to an FDA news release, Wegovy was studied and tested for this new indication in a “multi-national, multi-center, placebo-controlled double blind trial” that included over seventeen thousand participants. While all participants had similar underlying conditions and were provided standard medical treatment as controlling factors, they were split as to whether they received either Wegovy or a placebo. As it turns out, only 6.5% of the trial group that received the Wegovy medication suffered an adverse cardiovascular event, as opposed to 8% of the placebo group. Based on these findings, the FDA determined that Wegovy had the effect of significantly decreasing the risk of major adverse cardiovascular events and approved the drug for its new indication.

STAT News adds “This is definitely… an opportunity for patients with both cardiovascular disease and obesity to potentially get this drug [through Medicare] when they couldn’t get it just for obesity alone,” said Juliette Cubanski, deputy director of the Program on Medicare Policy at KFF.” 

As Wegovy continues to broaden its scope of usage and gains popularity, healthcare professionals still need to be diligent about informing patients of best practices for Wegovy treatment. In addition to being informed of the possibility of experiencing serious adverse side effects, patients should be encouraged to only use the medication in addition to a reduced caloric diet and increased physical activity.

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