FDA said a new version of a popular diabetes medicine could be sold as a weight-loss drug in the U.S. The Food and Drug Administration approved Wegovy, a higher-dose version of Novo Nordisk’s diabetes drug semaglutide.
In company-funded studies, an average of 15% weight loss had happened to the participants taking Wegovy, about 34 pounds (15.3 kilograms). Participants lost weight steadily for 16 months before plateauing. In a comparison group getting dummy shots, the average weight loss was about 2.5%, or just under 6 pounds.
“With existing drugs, you’re going to get maybe 5% to 10% weight reduction, sometimes not even that,” said Dr. Harold Bays, medical director of the Louisville Metabolic and Atherosclerosis Research Center. Bays, who is also the Obesity Medicine Association’s chief science officer, helped run studies of the drug.
In the U.S., more than 100 million adults — about 1 in 3 — are obese.
Dropping even 5% of one’s weight can bring health benefits, such as improved energy, blood pressure, blood sugar and cholesterol levels, but that amount often doesn’t satisfy patients who are focused on weight loss, Bays said.
The drug bears a potential risk for a type of thyroid tumor, so it shouldn’t be taken by people with a personal or family history of certain thyroid and endocrine tumors. Wegovy also has a risk of depression and pancreas inflammation.
Wegovy (pronounced wee-GOH’-vee) is a synthesized version of a gut hormone that curbs appetite. Patients inject it weekly under their skin. Like other weight-loss drugs, it’s to be used along with exercise, a healthy diet and other steps like keeping a food diary.
The Danish company hasn’t disclosed Wegovy’s price but said it will be similar to the price of its Saxenda, a weight loss drug injected daily that now typically costs more than $1,300 per month without insurance.