Semaglutide, a GLP-1 receptor agonist from Novo Nordisk, originally developed to treat diabetes, has been approved by the U.S. Food and Drug Administration (FDA) as a way to reduce the risk of major adverse cardiovascular events in patients who are overweight or obese and present with cardiovascular disease (CVD).
Novo Nordisk sells and markets its weekly subcutaneous treatments of semaglutide 2.4 mg under the brand name Wegovy. Prior research has already confirmed Wegovy can help overweight and obese patients lose weight. The company also sells a slightly different form of semaglutide under the brand name Ozempic.
The FDA highlighted the importance of this news with a special announcement, noting that this is the first approval of its kind.
“Wegovy is now the first weight loss medication to also be approved to help prevent life-threatening cardiovascular events in adults with CVD and either obesity or overweight,” John Sharretts, MD, director of the division of diabetes, lipid disorders and obesity in the FDA’s Center for Drug Evaluation and Research, said in the statement. “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.”
The FDA’s decision is largely based on data from the SELECT trial, which included more than 17,000 overweight or obese patients with a baseline age of 45 years old. All presented with CVD but no history of diabetes. Overall, treatment with semaglutide was associated with a reduction in the study’s composite outcome—cardiovascular death, nonfatal myocardial infarction or nonfatal stroke—of 20% compared to a placebo, and it was linked to a “safe and well-tolerated profile.”
SELECT trial results were published in the New England Journal of Medicine in November.
“We are very pleased that Wegovy is now approved in the U.S. as the first therapy to help people manage their weight and reduce cardiovascular risks,” Martin Holst Lange, executive vice president and head of development at Novo Nordisk, said in a separate statement. “This approval is an important milestone for people living with obesity and cardiovascular disease, as the SELECT data demonstrated that Wegovy has the potential to prolong lives by addressing some of the leading causes of preventable deaths by reducing the risks of cardiovascular events.”
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.