Danish Company Secures FDA Approval for Drug Used to Treat Diabetes, Weight Loss

A popular diabetes medication made by Novo Nordisk has been approved to be sold in the U.S. as a weight-loss drug by the Food and Drug Administration, the Associated Press reported on Friday.

Wegovy is a higher-dose version of Novo Nordisk's semaglutide. Studies have shown that patients taking Wegovy experienced an average weight loss of 15 percent, about 34 pounds. The participants in the study lost weight steadily over a 16-month period. Meanwhile, those receiving dummy shots lost an average of 2.5 percent of their weight.

Dr. Harold Bays, medical director of the Louisville Metabolic and Atherosclerosis Research Center, helped run the studies on Wegovy, as well as other obesity and diabetes drugs.

"With existing drugs, you're going to get maybe five percent to 10 percent with reduction, sometimes not even that," he said.

For more reporting from the Associated Press, see below:

Cycling for Changing Diabetes
Peter Kusztor of Hungary, Andrea Peron of Italy, Umberto Poli of Italy, David Lozano Riba of Spain, Joonas Henttala of Finland, Oliver Behringer of Switzerland, Logan Phippen of United States and Team Novo Nordisk during the 56th Presidential Cycling Tour Of Turkey 2021 Stuart Franklin/Getty Images

In the U.S., more than 100 million adults—about one in three—are obese.

Dropping even five percent of one's weight can bring health benefits, such as improved energy, blood pressure, blood sugar and cholesterol levels, but it often doesn't satisfy patients who are focused on weight loss, Bays said.

Bays said Wegovy appears far safer than earlier obesity drugs that "have gone down in flames" over safety problems. Wegovy's most common side effects were nausea, diarrhea and vomiting. Those usually subsided but led about five percent of study participants to stop taking it.

The drug also shouldn't be given to people at risk for some cancers, because of potential risk for certain thyroid tumors, the FDA said.

Patients inject Wegovy (pronounced wee-GOH'-vee) 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.

Novo Nordisk sells two semaglutide versions for controlling blood sugar in type 2 diabetics: a daily pill called Rybelsus and Ozempic, which patients inject weekly. The Danish company hasn't disclosed Wegovy's list price, but Ozempic typically costs $850 or more per month without insurance.

Wegovy builds on a trend in which makers of relatively new diabetes drugs test them to treat other conditions common in diabetics. For example, popular diabetes drugs Jardiance and Novo Nordisk's Victoza now have approvals for reducing the risk of heart attack, stroke and death in heart patients.

Phylander Pannell, 49, of Largo, Maryland, joined a patient study after cycles of losing and then regaining weight. She said she received Wegovy, worked out several times a week and lost 65 pounds over 16 months.

"It helped curb my appetite and it helped me feel full faster," said Pannell. "It got me on the right path."

Shortly after she finished the study and stopped receiving Wegovy, she regained about half the weight. She's since lost much of that, started exercise classes and bought home exercise equipment. She's considering going back on Wegovy after it's approved.

Wegovy is a synthesized version of a gut hormone that curbs appetite. That's a new strategy in treating obesity, said Dr. Robert Kushner, a member of Novo Nordisk's medical advisory board who heads Northwestern Medicine's Center for Lifestyle Medicine.

Novo Nordisk also is developing a pill version that should start final patient studies later this year.

Obesity School, Reedley, California, 2008
Wellspring Academy of California, a boarding school for obese teenagers, is the first boarding school for weight loss in the United States. Macy Marquez (L) hits the gym late at night. Most students had been leaving a sedentary lifestyle prior to enrolling at the Wellspring Academy. Children come from as far as Mexico, Scotland and even Kuwait to attend the school. Stephan Gladieu/Getty Images