FDA Approves Wegovy as First Weight-Loss Drug to Reduce Heart Attack and Stroke Risk

The U.S. Food and Drug Administration has approved the weight-loss drug semaglutide — sold under the brand name Wegovy — for a new and landmark indication: reducing the risk of heart attacks, strokes, and cardiovascular death in adults who are overweight or obese, regardless of whether they have diabetes. The approval, confirmed in March 2024, made Wegovy the first anti-obesity medication in history to receive regulatory clearance specifically for its cardiovascular benefits — a development widely described by cardiologists as a turning point in the treatment of obesity. The FDA's decision followed the results of the SELECT trial, one of the largest cardiovascular outcomes studies ever conducted for a weight-loss drug. The trial enrolled more than 17,500 adults who had established cardiovascular disease — meaning they had already had a heart attack or stroke, or had confirmed coronary artery disease — and a body mass index of 27 or higher, without a diagnosis of type 2 diabetes. Participants who received weekly subcutaneous injections of semaglutide experienced a 20 per cent reduction in major adverse cardiovascular events compared to those who received a placebo, over an average follow-up period of more than three years. Major adverse cardiovascular events in the trial included non-fatal heart attack, non-fatal stroke, and cardiovascular death. Semaglutide belongs to a class of medications known as glucagon-like peptide-1 (GLP-1) receptor agonists, first developed to manage blood sugar levels in patients with type 2 diabetes. The drugs work by mimicking a hormone naturally released by the gut after eating, which stimulates insulin secretion, suppresses appetite, and slows the rate at which the stomach empties. Their pronounced effect on body weight — typically producing reductions of between 10 and 15 per cent in clinical trials — led researchers to investigate their potential in populations without diabetes. The expanded cardiovascular indication means that eligible patients can now receive Wegovy with heart disease risk reduction as a clinical justification, a change that may significantly affect insurance coverage decisions in the United States and regulatory reviews underway in other countries. Access and affordability remain the central challenge. Wegovy carries a list price of approximately USD 1,300 per month in the United States without insurance, placing it out of reach for many of the patients who would most benefit. Health economists and patient advocacy groups have called on governments and insurers to act swiftly, given the scale of both the obesity and cardiovascular disease epidemics globally. The approval has also accelerated research into other potential benefits of the GLP-1 drug class, with ongoing trials examining their effects on kidney disease, liver disease, sleep apnoea, and neurological conditions including Alzheimer's disease.