FDA approves Wegovy to lower heart attack and stroke risk in adults with heart disease plus obesity
The new use covers only patients who already have heart disease plus excess weight, but it gives Medicare Part D a covered indication that is not weight loss.
The FDA on March 8, 2024 approved a new use for Wegovy (semaglutide) injection: lowering the risk of heart attacks, strokes and cardiovascular deaths in adults who already have heart disease and are also obese or overweight [1]. The drug is meant to be taken along with a reduced-calorie diet and increased physical activity [1].
"This patient population has a higher risk of cardiovascular death, heart attack and stroke," said John Sharretts, M.D., director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA's Center for Drug Evaluation and Research. "Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health" [1].
About 70% of American adults have obesity or overweight, conditions the agency said raise the risk of premature death and of health problems including heart attack and stroke [1]. Wegovy has been on the market since June 4, 2021, when it was first cleared for weight management [3]. The FDA granted this approval to Novo Nordisk A/S and reviewed the application under Priority Review [1].
The trial behind the decision
The evidence came from a multinational, multicenter, placebo-controlled, double-blind study that randomly assigned more than 17,600 participants to Wegovy or a placebo; the trial is registered as NCT03574597 [1][2]. Everyone in the study also received standard medical care, such as treatment for blood pressure and cholesterol, plus counseling on diet and physical activity [1].
Major adverse cardiovascular events — cardiovascular death, heart attack and stroke — occurred in 6.5% of the Wegovy group and 8% of the placebo group [1]. The FDA announcement did not include a relative risk reduction or a confidence interval for that difference. A Novo Nordisk announcement listed in a Wegovy approval timeline reported that semaglutide 2.4 mg reduced the risk of these events by 20% in the SELECT trial [3].
Safety information the label carries
Wegovy's prescribing information includes a boxed warning about thyroid C-cell tumors, and the drug is not for people with a personal or family history of medullary thyroid carcinoma or with a rare condition called Multiple Endocrine Neoplasia syndrome type 2 [1]. It also should not be used by anyone who has had a severe allergic reaction to semaglutide or to another ingredient in the product [1].
Other warnings in the label cover inflammation of the pancreas, gallbladder problems including gallstones, low blood sugar, acute kidney injury, allergic reactions, diabetic retinopathy, a faster heart rate, and suicidal thoughts or behavior [1]. The most frequently reported side effects include nausea, diarrhea, vomiting, constipation, stomach pain, headache, fatigue, indigestion, dizziness, bloating, belching, low blood sugar in people with diabetes, gas and heartburn [1]. Wegovy should not be combined with other semaglutide products or with other GLP-1 receptor agonists [1].
Why it matters for patients
Medicare Part D has been barred by law from paying for drugs used for weight loss since the program began in 2006 [4]. Cardiovascular risk reduction is a different use, so this approval gives Part D plans a legal path to cover Wegovy for patients who fit the label's criteria: established cardiovascular disease plus obesity or overweight [4].
That path is not a guarantee. Medicare keeps no national list of covered GLP-1 drugs; each Part D plan writes its own formulary, and coverage of these medicines commonly comes with prior authorization, meaning a prescriber has to document why the drug is being ordered [4]. Plans also put drugs on different tiers, which changes what a member pays [4].
The decision applies to Wegovy. Other GLP-1 medicines carry their own approved indications and are covered, or not, according to those labels, so this approval does not change their status [4]. A patient whose only qualifying diagnosis is obesity still falls under the weight-loss exclusion [4].
What happens next
Formularies are redrawn every January, so whether a plan covers Wegovy for this use can change from year to year; Medicare's open enrollment period runs from October 15 to December 7 [4]. How many plans will adopt the cardiovascular indication, and how quickly, has not been reported in a national list [4]. Wegovy also remains approved for reducing excess weight and maintaining weight loss in certain adults with obesity or overweight and in certain children with obesity [1].
Sources
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