FDA approves Wegovy to cut heart attack and stroke risk
The FDA cleared Wegovy (semaglutide) to lower the risk of cardiovascular death, heart attack and stroke in adults with heart disease plus obesity or overweight — the first obesity drug with such an indication, and one Medicare can pay for.
The U.S. Food and Drug Administration on March 8, 2024 approved a new indication for Wegovy (semaglutide) injection: reducing the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease and either obesity or overweight [1]. The agency said Wegovy is "the first weight loss medication to also be approved to help prevent life-threatening cardiovascular events" in that group, according to John Sharretts, M.D., director of the FDA division that oversees obesity drugs [1].
What the trial showed
The approval rests on a multi-national, multi-center, placebo-controlled, double-blind trial that randomly assigned more than 17,600 participants to Wegovy or placebo [1]. Everyone in both groups also received standard-of-care medical treatment, such as blood pressure and cholesterol management, plus healthy lifestyle counseling on diet and physical activity [1].
Major adverse cardiovascular events — cardiovascular death, heart attack and stroke — occurred in 6.5% of participants who received Wegovy compared with 8% of those on placebo [1]. That is a difference of about 1.5 percentage points. The FDA's announcement does not state how long participants were followed, so the time frame behind those numbers is not given in the agency's release [1].
Wegovy is meant to be used in addition to a reduced-calorie diet and increased physical activity [1]. The indication received Priority Review, and the approval went to Novo Nordisk A/S [1].
There is a small wording difference across sources. The FDA press release describes the population as "adults with cardiovascular disease and either obesity or overweight" [1], while the prescribing information as summarized by Drugs.com specifies "established cardiovascular disease" and defines the events as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke [3].
Safety information stays the same
The new use does not change Wegovy's safety labeling. The prescribing information carries a boxed warning about the risk of thyroid C-cell tumors, and the drug should not be used by people with a personal or family history of medullary thyroid carcinoma or with Multiple Endocrine Neoplasia syndrome type 2 [1]. Because Wegovy contains a GLP-1 receptor agonist, it should not be combined with other semaglutide-containing products or other GLP-1 drugs [1].
Other labeled warnings include pancreatitis, gallbladder problems including gallstones, low blood sugar, acute kidney injury, hypersensitivity reactions, diabetic retinopathy, increased heart rate, and suicidal behavior or thinking [1]. The most common side effects include nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, indigestion, dizziness, bloating, belching, gas and heartburn [1].
Why it matters for patients
The practical consequence goes beyond the label. Medicare Part D is barred by statute from paying for drugs used for weight loss — an exclusion written into the law when Part D launched in 2006 [4]. Because cardiovascular risk reduction is a different indication, Wegovy prescribed for that purpose became coverable under Part D, and later coverage guidance lists it among the GLP-1 uses Medicare pays for, with formularies and prior authorization rules still varying plan by plan [4].
The indication is narrow. It applies to adults who have established cardiovascular disease and obesity or overweight [3] — not to everyone seeking weight loss, even though obesity or overweight affect roughly 70% of American adults [1]. Coverage is also not automatic: plans typically require documentation of the qualifying diagnosis, and the prescription must be written for that indication [4].
Also worth keeping in perspective: the trial compared Wegovy against placebo on top of standard cardiac care, not against other GLP-1 drugs [1]. Whether other medicines in this class produce similar results was not addressed by this approval.
What happens next
Wegovy was first approved for weight management on June 4, 2021, and for obesity in adolescents aged 12 and older on December 23, 2022 [3]. After the March 2024 cardiovascular approval, the label continued to expand: accelerated approval for noncirrhotic MASH with F2–F3 fibrosis on August 15, 2025, and an oral Wegovy tablet on December 22, 2025 [3].
On the coverage side, a CMS demonstration called the Medicare GLP-1 Bridge began July 1, 2026 and runs through December 31, 2027, covering Wegovy, the Zepbound KwikPen and Foundayo (orforglipron) for weight management at a flat $50 a month; people whose GLP-1 is already coverable under Part D — including for cardiovascular risk — are excluded from it [4].
Sources
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