Breaking: FDA Approves Wegovy to Reduce Cardiovascular Risks in Overweight, Obesity
Study results demonstrated the efficacy of semaglutide (Wegovy) in reducing cardiovascular risks in adults with overweight or obesity without diabetes.
Semaglutide (Wegovy) has earned FDA approval for a new indication: in addition to treating overweight and obesity in adults and children aged 12 years and older, Novo Nordisk’s injection can now be used to reduce the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease and either overweight or obesity.1,2
The FDA granted the glucagon-like peptide-1 (GLP-1) receptor agonist a priority review designation for this indication.
The agency’s decision comes after an analysis of data from the multicenter, multinational, double-blind, placebo-controlled, phase 3 SELECT clinical trial (NCT03574597). These data were presented in a late-breaking abstract at the 2023 American Heart Association (AHA) Scientific Sessions, held November 11 to 13, 2023, in Philadelphia, Pennsylvania and were simultaneously published in the New England Journal of Medicine.3,4
The new FDA indication approves semaglutide for use in adults with overweight or obesity and cardiovascular disease. | image credt: catalin - stock.adobe.com
Researchers for the select trial sought to demonstrate if semaglutide, which previously demonstrated efficacy in reducing major adverse cardiovascular events (MACE) in adults with type 2 diabetes, could also reduce that risk in adults with overweight and obesity. Investigators randomly assigned a cohort of 17,604 patients aged 45 years and older with pre-existing cardiovascular disease to receive either once-weekly subcutaneous semaglutide 2.4 mg (n=8803) or placebo (n=8801), as well as standard of care for cardiovascular disease, which included any cholesterol, antiplatelet, or beta blocker therapies.
The study’s primary cardiovascular endpoint was any component of composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke in a time-to-first event analysis. Results showed a 28% reduction in nonfatal myocardial infarction, a 15% reduction in cardiovascular death, and a 7% reduction in nonfatal stroke compared with the placebo group (HR, 0.72, 0.85, and 0.93, respectively); reduction in the risk of cardiovascular death was not statistically significant over the duration of the trial.
Additionally, participants in the semaglutide group experienced an average body weight reduction of 9.4% (vs 0.9% with placebo).
READ MORE: Pharmacy Compounders Defend Semaglutide Compounding Amid Continued Shortages
Serious adverse events occurred in 33.4% and 36.4% of the semaglutide and treatment groups, respectively; 16.6% and 8.2% of those adverse events led to permanent discontinuation of semaglutide or placebo therapy.
Study limitations include a lack of diversity in the study population relative to the general population—only 3.8% of participants were Black, and only 27.7% were women—and the focus of the trial on individuals with preexisting CVD, limiting potential conclusions about the role of semaglutide on primary prevention of cardiovascular events in adults with overweight or obesity.
“For the first time, we have evidence that semaglutide 2.4 mg improves cardiovascular outcomes in at-risk patients with a BMI of 27 and above with established CVD, without diabetes,” noted Michael Lincoff, MD, lead study author, vice chair for research in the Department of Cardiovascular Medicine, and an interventional cardiologist in the Sydell and Arnold Miller Family Heart, Vascular, and Thoracic Institute, both at the Cleveland Clinic, during the Scientific Sessions.4,5 “The 3-point MACE risk reduction…suggests the potential for a new option in obesity treatment, addressing some of the leading causes of preventable death worldwide.”
Approximately 70% of American adults are living with overweight or obesity, both serious health issues that increase a person’s risk for premature death and other health problems such as heart attack and stroke.
“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,” said John Sharretts, MD, director of the Division of Diabetes, Lipid Disorders, and Obesity at the FDA’s Center for Drug Evaluation and Research.1
“This approval is an important milestone for people living with obesity and cardiovascular disease,” said Novo Nordisk executive vice president and head of Development in a company press release.2 “[Semaglutide] has the potential to prolong lives by adding some of the leading causes of preventable deaths by reducing the risk of cardiovascular events.”
Disclosures: Lincoff is a paid consultant for Novo Nordisk. Multiple study authors reported relationships with Novo Nordisk and other industry stakeholders. For a full list of disclosures, see the full text of the study in the New England Journal of Medicine.
READ MORE: Cardiology Resource Center
References
FDA approves first treatment to reduce risk of serious heart problems specifically in adults with overweight or obesity. 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
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
Lincoff MA, Brown-Frandsen K, Colhoun HM, et al; for the SELECT Trial Investigators. Semaglutide and cardiovascular outcomes in obesity without diabetes. N Engl J Med. 2023;389:2221-2232. doi:10.1056/NEJMoa2307563
Biscaldi L. AHA: Semaglutide significantly reduces MACE in adults with overweight or obesity, CVD. Drug Topics. November 14, 2023. Accessed March 8, 2024. https://www.drugtopics.com/view/aha-semaglutide-significantly-reduces-mace-in-adults-with-overweight-or-obesity-cvd
Major CVD event risk cut by 20% in adults without diabetes, with overweight or obesity. News release. American Heart Association. November 11, 2023. Accessed March 8, 2024. https://newsroom.heart.org/news/major-cvd-event-risk-cut-by-20-in-adults-without-diabetes-with-overweight-or-obesity
