Novo Nordisk’s weight loss medication Wegovy received approval on Friday for reducing the risk of cardiovascular death, heart attack and stroke in patients with cardiovascular disease and obesity.
The Food and Drug Administration (FDA) cited the results of a multi-national study that involved 17,600 participants who either received Wegovy or a placebo. The results found that the risk of a major adverse cardiovascular events was statistically reduced to 20 percent among patients who received the drug.
These benefits were observed among participants regardless of “baseline age, sex, race, ethnicity, body mass index (BMI) and level of renal function impairment.” Novo Nordisk noted the mechanism through which this reduction occurs has not yet been established.
“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,” John Sharretts, director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, said in a statement.
Martin Holst Lange, executive vice president and head of Development at Novo Nordisk, called the approval an “important milestone for people living with obesity and cardiovascular disease.”
“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,” said Lange.
Wegovy falls within the class of medication known as GLP-1 agonists which are used to manage diabetes as obesity by mimicking the GLP-1 hormone that stimulates insulin secretion. Other drugs in this class include Ozempic, Mounjaro and Zepbound.