The Food and Drug Administration (FDA) approved the label expansion, citing the results from a multinational study that found that use of Wegovy caused a 20 percent decrease in the risk of major adverse cardiovascular events.
The label change comes after a late-stage clinical trial of more than 17,000 people who either received Wegovy or a placebo.
Wegovy’s manufacturer Novo Nordisk noted that benefits were observed among study participants regardless of “baseline age, sex, race, ethnicity, body mass index (BMI) and level of renal function impairment.”
The active ingredient in Wegovy is semaglutide, part of a class of drugs known GLP-1 agonists that so far have only been approved for use in treating obesity and diabetes. Other commonly known medications in this class Ozempic, Mounjaro and Zepbound.
Heart disease is the leading cause of death in the U.S., according to the Centers for Disease and Prevention. The expanded label could lead to more insurers covering the medication.
Medicare is not allowed to cover weight loss drugs, and many private insurers have balked at the cost, forcing patients who need the drugs to pay thousands of dollars. Before any discounts, Wegovy costs $1,300 a month.
The label expansion means Wegovy is now the medication to help people manage weight and also help prevent life-threatening risk of heart disease, Novo Nordisk said.
Like other GLP-1 medications, Wegovy remains in shortage as manufacturers struggle to keep up with demand. Novo Nordisk said last month it is starting to increase availability and will gradually increase overall supply throughout this year.
