FDA clears Wegovy’s label to include heart health benefits

Novo Nordisk’s Wegovy has been given a first-in-class approval by the FDA to reduce the risk of serious cardiovascular conditions in people who are overweight or obese.

The green light could help to expand insurance coverage of Wegovy (semaglutide) in the US, which is already growing at a phenomenal rate on the back of soaring demand among people who want to use it to lose weight and are often prepared to pay for the drug out of pocket.

Some insurance companies have baulked at providing coverage for Wegovy and other GLP-1 agonist drugs for obesity, arguing that the cost is too great unless there is clear evidence of health benefits beyond weight loss.

Moreover, reimbursement of all anti-obesity medicines is prohibited under Medicare Part D, a voluntary outpatient prescription drug benefit for Medicare recipients, but the new heart health approval could remove that block.

“Wegovy is now the first weight loss medication to also be approved to help prevent life-threatening cardiovascular events in adults with cardiovascular disease and either obesity or [who are] overweight,” said John Sharretts, director of the FDA’s division of diabetes, lipid disorders, and obesity.

“This patient population has a higher risk of cardiovascular death, heart attack, and stroke,” he added, noting that around 70% of US adults are overweight or obese. “Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health.”

Wegovy was first cleared for obesity in adults in 2021 and had its label extended in 2022 to include adolescents aged 12 and over. Last year, the drug brought in sales of around $4.5 billion, despite Novo Nordisk struggling to ramp up production to meet demand.

The patient organisation Obesity Action Coalition (OAC) said in a statement that the new approval should spell the end of any insurance barriers in front of access to Wegovy.

“Payers should have been providing coverage for anti-obesity medications prior to the announcement,” it said.” Now, there should be no doubt that this treatment must be covered. Lives are at stake.”

The SELECT trial of Wegovy showed a 20% reduction in cardiovascular outcomes, including cardiovascular death, non-fatal heart attack (myocardial infarction), or non-fatal stroke when used in overweight or obese patients who had underlying cardiovascular disease.

The improvement was seen regardless of patients’ baseline age, sex, race, ethnicity, body mass index (BMI), and level of renal function impairment. Moreover, treatment with Wegovy also achieved a 37% reduction in an even broader composite endpoint that included cardiovascular death, coronary revascularisation, myocardial infarction, stroke, hospitalisation for heart failure or unstable angina, nephropathy, and diabetes.

At its recent capital markets day, Novo Nordisk told investors and analysts that it expects anti-obesity medications “to be mostly out-of-pocket, with SELECT as a key lever to improve reimbursement […] and market access.”

The company has also filed for a label expansion in the EU based on the SELECT data and said a decision is expected there later this year.