The US Food and Drug Administration (FDA) has approved an additional indication for the weight loss drug semaglutide—marketed as Wegovy (Novo Nordisk) —to reduce the risk of major cardiovascular events such as death, heart attack, or stroke in adults with known heart disease and with either obesity or overweight along with a reduced calorie diet and increased physical activity.
This new indication adds to the prescribing label for Wegovy, a prescription-only medicine previously approved for adults and children aged 12 years and older with obesity, or some adults with overweight who also have weight-related medical problems, to help them lose excess body weight and keep the weight off when used along with a reduced calorie diet and increased physical activity.
“Today, we’re taking a pivotal step forward in addressing some of the most pressing health issues of our time with the added indication for Wegovy,” said Doug Langa, executive vice president, head of North America operations, and president of Novo Nordisk. “We recognise 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. 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.”
The FDA decision is based on the results of the landmark SELECT phase 3 cardiovascular outcomes trial that examined the effect of adding Wegovy 2.4mg or placebo to cardiovascular standard of care in adults with overweight and obesity with established cardiovascular disease and without diabetes.
Presented at the American Heart Association’s 2023 Scientific Sessions (11–13 November, Philadelphia, USA), the results of the SELECT trial showed that overweight or obese people without diabetes taking semaglutide for more than three years had a 20% lower risk of heart attack, stroke or death due to cardiovascular disease and lost an average of 9.4% of their body weight.
“This approval is a significant decision because people living with excess weight or obesity and established cardiovascular disease and without diabetes have never had an FDA-approved treatment option that lowers weight and reduces the likelihood of another cardiovascular event,” said A Michael Lincoff (Cleveland Clinic, Cleveland, USA) and the lead study author of the SELECT outcomes trial. “For healthcare professionals, this approval provides a new treatment option to help us address cardiovascular residual risk that remains for patients on current standard of care.”
“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, director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research. “This patient population has a higher risk of cardiovascular death, heart attack and stroke. Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health.”
