FDA approves obesity drug that helped people cut weight 15%

Regulators on Friday 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, participants taking Wegovy had average weight loss of 15%, 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 Wegovy and other obesity and diabetes drugs.

In the U.S., more than 100 million adults — about one in three — 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 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 5% of study participants to stop taking it.

The drug also shouldn’t be given to people at risk for some cancers, because of a 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 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.

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Follow Linda A. Johnson at https://twitter.com/LindaJ_onPharma.

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Linda A. Johnson, The Associated Press