FDA Approves Semaglutide for New Indication Involving Cardiovascular Disease


Semaglutide (Wegovy; Novo Nordisk) reduces the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease and either obesity or overweight when combined with the standard-of-care.

The FDA has approved a new indication for the use of semaglutide (Wegovy: Novo Nordisk) to reduce the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease (CVD) and either obesity or overweight, according to a press release from the agency. The medication should be used in addition to reduced calorie diet and increased physical activity.1

Fda approved red band sign | Image Credit: Aquir - stock.adobe.com

Image Credit: Aquir - stock.adobe.com

“Wegovy is now the first weight loss medication to also be approved to help prevent life-threatening cardiovascular events in adults with [CVD] and either obesity or overweight,” John Sharretts, MD, director of the Division of Diabetes, Lipid Disorders, and Obesity in the Center for Drug Evaluation and Research at the FDA, said in the 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.”1

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor antagonist, a class of medications that has gathered much media attention as of late.1 The FDA said that semaglutide should not be used in combination with other medication containing semaglutide or other GLP-1 receptor agonists.1

The approval was based on efficacy and safety in the multicentered, placebo controlled, double-blind SELECT (NCT03574597) trial, which had over 17,600 individuals in the cohort. Treatment was randomized between semaglutide or the placebo, with both groups receiving standard-of-care treatment, including management of blood pressure and cholesterol, and healthy lifestyle counseling, including diet and physical activity, according to the FDA.1,2

Investigators of the study found that semaglutide significantly reduced the risk of major adverse cardiovascular events (MACE) such as CVD death, heart attack, and stroke, which occurred in 6.5% of individuals in the semaglutide group compared with 8% of those in the placebo group.1

The findings from the SELECT trial showed that the risk of MACEs was reduced by 20% compared with the placebo in combination with standard of care. Further, it showed that over 5 years, the reduction was seen regardless of baseline age, sex, race, ethnicity, body mass index, and level of renal function impairment, according to a press release from Novo Nordisk. The label is updated to include data from the SELECT trial, indicating a reduction in CVD-related death by 15% and all-cause death by 19%.2

Key Takeaways

  1. The FDA approved Wegovy (semaglutide) for a new use: reducing the risk of cardiovascular (CV) death, heart attack, and stroke in adults with both cardiovascular disease (CVD) and overweight or obesity.
  2. Wegovy is the first weight-loss medication approved for this specific purpose.
  3. It should be used alongside a reduced-calorie diet and increased physical activity.

The most common adverse events included nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, indigestion, dizziness, and hypoglycemia in patients with diabetes, according to the FDA press release.1

This approval comes after the FDA granted priority review to semaglutide for this indication. Semaglutide is also approved to reduce excess weight and maintain weight reduction in the long term in certain adults with obesity or overweight as well as certain children with obesity. Further, it should also be used in addition to a reduced calorie diet and increased physical activity, according to the FDA press release.1

  1. FDA Approves First Treatment to Reduce Risk of Serious Heart Problems Specifically in Adults with Obesity or Overweight. News release. FDA. March 8, 2024. Accessed March 8, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-reduce-risk-serious-heart-problems-specifically-adults-obesity-or
  2. Wegovy approved in the US for cardiovascular risk reduction in people with overweight or obesity and established cardiovascular disease. News release. Novo Nordisk. March 8, 2024. Accessed March 8, 2024. https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=167030
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