Wegovy Can Now Be Prescribed for Its Heart Health Benefits

Popular weight-loss drug Wegovy has received approval from the United States Food and Drug Administration (FDA) for a new indication for use: to reduce the risk of serious heart problems in adults who are at a higher risk of experiencing them.

Wegovy can now indicate on its label that it works to reduce the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease who are either obese or overweight, according to an announcement from the FDA.

The FDA announced the approval last week, indicating that Wegovy — which contains the drug semaglutide, a 1 (GLP-1) receptor agonist — should be used in addition to a reduced-calorie diet and increased physical activity.

The new indication for use may result in improved insurance coverage for the drug, which isn’t currently covered by many insurers and costs $1,349 per month.

“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 overweight,” said John Sharretts, M.D., the director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, in a news release. “This patient population has a higher risk of cardiovascular death, heart attack and stroke.”

The drug’s ability to reduce cardiovascular risks was demonstrated in a multi-national, multi-center, placebo-controlled double-blind trial in which over 17,600 participants were randomly assigned to receive either Wegovy or a placebo. All participants also received help with managing blood pressure and cholesterol and healthy lifestyle counseling on diet and exercise.

The study found that Wegovy significantly reduced the risk of major adverse cardiovascular events, including cardiovascular death, heart attack, and stroke. These negative health outcomes occurred in 6.5% of participants who received Wegovy, as opposed to 8% of participants who received the placebo — representing a risk reduction of 20%.

“Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health,” Sharretts said.

Wegovy’s label now indicates that it can be used to reduce the risk of major adverse cardiovascular events in adults with established cardiovascular disease and either obesity or overweight, as well as to reduce excess body weight and maintain weight reduction long-term in both adults and pediatric patients aged 12 years and older with obesity, and adults who are overweight and have at least one weight-related comorbid condition.

Similar GLP-1 drugs have seen massive shortages amidst increased demands as of late. Novo Nordisk, the company that manufactures Wegovy, says it is working to increase supply.

"We recognize how important this moment is for the millions of people who live with excess weight or obesity and known heart disease, and we will continue to advance options that put their needs first,” said Doug Langa, the executive vice president, head of North America Operations, and president of Novo Nordisk Inc., in a news release about the announcement. “Reducing this risk is a key part of our commitment to driving change for this community as we work to increase manufacturing capacity to responsibly supply this important medicine."

“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 overweight,” said John Sharretts, M.D., the director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, in a news release. “This patient population has a higher risk of cardiovascular death, heart attack and stroke.”


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