Wegovy has been approved for use as a heart disease prevention medication, the FDA announced on Friday.
The injectable semaglutide — originally approved for weight loss for certain patients — is now also indicated to reduce the risk of cardiovascular death, heart attack and stroke in adults who have cardiovascular disease and are either overweight or obese, the announcement stated.
“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 John Sharretts, M.D., director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, in the press release.
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“This patient population has a higher risk of cardiovascular death, heart attack and stroke,” he also said.
“Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health.”
Wegovy, which is made by Denmark-based Novo Nordisk, is a glucagon-like peptide-1 (GLP-1) receptor agonist that should not be taken with other semaglutide or GLP-1 products, the FDA stated.
The approval comes after a large, randomized, double-blind trial that included 17,600 participants in two groups.
Both groups received “standard-of-care medical treatment (e.g., management of blood pressure and cholesterol) and healthy lifestyle counseling (including diet and physical activity).”
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In the trial, the group that took Wegovy showed a significant reduction in cardiovascular death, heart attack and stroke.
Brooke Boyarsky Pratt, the CEO of knownwell, a Boston-based weight management company, said the announcement marked “an exciting day” for patients with heart disease as well as their doctors.
“This approval is an important step in getting patients access to potentially life-saving medication,” Pratt said in a statement to Fox News Digital.
“It continues to support what the medical community has known all along — GLP-1s are here to treat serious chronic diseases, now cardiovascular disease in addition to diabetes and obesity.”
The FDA’s approval is a step in the right direction toward battling the “bias and stigma” around these medications, she said.
“Significantly reducing the risk of cardiac disease in patients who are at a higher risk is incredibly important to both patients and clinicians,” Pratt went on.
“We hope that with this indication, these patients who unfortunately may not have had coverage for these medications before will soon find them covered.”
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Dr. Darren McGuire, a cardiologist at UT Southwestern in Dallas, Texas, called the FDA’s approval a “landmark decision in the field of medical therapy for obesity.”
He told Fox News Digital, “With this FDA action, semaglutide becomes the first medication ever in the U.S. approved for the treatment of persons living with obesity with anything beyond a claim of cardiovascular safety.”
The decision, McGuire said, reinforces what most medical experts have known for decades — “that reducing body weight for persons living with obesity would reduce risk for a broad spectrum of obesity-related complications, cardiovascular and otherwise.”
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McGuire, who is an expert in heart disease and prevention, especially among people with diabetes, predicts that approximately one in five U.S. adults would benefit from treatment with semaglutide.
“Conservatively, around 55 million U.S. adults have an indication for cardiovascular risk reduction with semaglutide,” he said.
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Looking ahead, McGuire predicts that many similar medications will enter the market in years to come.
“Presently, semaglutide is only one drug in one class with proof of cardiovascular efficacy and with FDA approval for such,” he told Fox News Digital. “Many more medications are presently being developed and tested similarly, so this field will rapidly evolve.”
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Patients should speak with a health care provider about the potential benefits and side effects of Wegovy, experts say.
Fox News Digital reached out to Novo Nordisk requesting additional comment.
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