FDA Approvals on Wegovy and Semaglutide
- Wegovy approved on March 8 to reduce cardiovascular risk in adults with heart disease and obesity.
- Semaglutide approved in 2021 for chronic weight management in adults with obesity or overweight.
- Semaglutide approved in 2017 to treat type 2 diabetes in adults.
The U.S. Food and Drug Administration (FDA) has recently expanded the approval of the semaglutide medication Wegovy, developed by Novo Nordisk, to include the reduction of cardiovascular death, heart attacks, and strokes in adults with cardiovascular disease who are overweight or obese. This decision follows the medication’s initial approval for chronic weight management in 2021 and as a treatment for type 2 diabetes in 2017.
Presented at the American Heart Association’s Epidemiology and Prevention Lifestyle and Cardiometabolic Scientific Sessions 2024 in Chicago, the endorsement is grounded in findings from the SELECT cardiovascular outcomes clinical trial. The study demonstrated a 20% decrease in major adverse cardiovascular events for individuals using Wegovy, alongside a 15% reduced risk of cardiovascular death and a 19% decrease in death from any cause, compared to a placebo group.
Semaglutide belongs to the class of glucagon-like peptide-1 (GLP-1) receptor agonists and mimics a natural hormone released during eating, promoting insulin production and reducing blood sugar levels. This mechanism not only aids in glucose control but also in weight loss and management, factors critically linked to reducing cardiovascular disease risks.
The FDA’s approval marks a significant advancement for heart disease prevention, addressing the needs in public health, especially given the persistent challenge of cardiovascular disease as the leading cause of death worldwide. This recognition opens a new chapter for semaglutide medications like Wegovy, not only in weight management but also as a pivotal treatment option for reducing cardiovascular risks in individuals faced with obesity.
References
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