FDA expands Wegovy indications, adding cardiovascular disease

On March 8, 2024, the United States FDA expanded approval of Wegovy (semaglutide), making it the first weight loss drug that is FDA-approved for obese and overweight patients at high risk for heart problems.

The updated approval allows doctors to prescribe the drug for these patients to reduce the risk of cardiovascular death, heart attack, and stroke. However, the FDA notes that lifestyle changes, such as a healthy diet and increased physical activity, should accompany this drug.

“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, MD, director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, in the FDA press release. “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 the FDA, this approval is based on SELECT, a phase 3, multi-national, multi-center, placebo-controlled, double-blind clinical trial with over 17,600 participants who were overweight or obese with cardiovascular disease risk.

Each participant was treated with lifestyle counseling and cardiovascular standard of care for overweight or obese adults without diabetes, which includes blood pressure and cholesterol management. Additionally, patients were assigned to receive 2.4 mg of Wegovy or a placebo.

The press release from Novo Nordisk, the manufacturer of Wegovy, highlights that 8.0% of participants in the control group experienced a major adverse cardiovascular event. In comparison, only 6.5% of the experimental group had that outcome. This data indicates that Wegovy is effective at reducing cardiovascular risk.

The study revealed that the drug was safe, with the most common adverse events including nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, indigestion, dizziness, abdominal distention, eructation, gas buildup, and heartburn.

"This approval is a significant decision because people living with excess weight or obesity and established cardiovascular disease and without diabetes have never had an FDA-approved treatment option that lowers weight and reduces the likelihood of another cardiovascular event," said A. Michael Lincoff, MD, Professor of Medicine at Cleveland Clinic and the lead study author of the SELECT outcomes trial, in the Novo Nordisk press release. "For healthcare professionals, this approval provides a new treatment option to help us address cardiovascular residual risk that remains for patients on current standard of care."