It is a significant development from the US FDA which has just given approval to Novo Nordisk’s Wegovy, a medication initially approved for weight loss, which has now also been approved to reduce the risk of cardiovascular events in adults. This groundbreaking decision marks Wegovy as the first weight-loss medication to be approved for preventing life-threatening heart conditions in individuals with cardiovascular disease who are overweight or obese.
Wegovy, an injectable semaglutide developed by Novo Nordisk, a Denmark-based pharmaceutical company, acts as a glucagon-like peptide-1 (GLP-1) receptor agonist. The FDA’s recent announcement highlights its effectiveness in lowering the risk of cardiovascular death, heart attack, and stroke among adults with pre-existing cardiovascular conditions. According to John Sharretts, M.D., director of the Division of Diabetes, Lipid Disorders, and Obesity at the FDA’s Center for Drug Evaluation and Research, this approval offers a significant advance for public health by providing a new treatment option to a patient population at elevated risk of serious cardiovascular events.
The approval of Wegovy for this new indication followed the results of a large, randomized, double-blind trial involving 17,600 participants. Participants in the trial received standard care, including management of blood pressure and cholesterol, along with healthy lifestyle counseling on diet and physical activity. Notably, the group treated with Wegovy exhibited a significant reduction in cardiovascular deaths, heart attacks, and strokes, underscoring the drug’s potential to offer substantial benefits beyond weight loss.
Brooke Boyarsky Pratt, CEO of Boston-based weight management company knownwell, hailed the FDA’s decision as a crucial step towards improving access to life-saving medications for patients with heart disease. She emphasized the importance of GLP-1s in treating serious chronic diseases, now including cardiovascular disease, alongside diabetes and obesity.
The FDA’s decision has been met with enthusiasm by medical professionals and is seen as a major milestone in the fight against obesity and related health issues. Dr. Darren McGuire, a cardiologist at UT Southwestern in Dallas, Texas, regarded it as a landmark decision in the medical therapy for obesity, emphasizing that semaglutide is the first medication in the U.S. approved for reducing cardiovascular risk in obese individuals beyond merely asserting cardiovascular safety.
This approval paves the way for future developments in the field, with McGuire predicting that many similar medications will enter the market, further evolving the treatment landscape for cardiovascular disease prevention.
