(AP) – Regulators said Friday that a new version of a popular diabetes drug could be sold in the US as a weight loss drug
The Food and Drug Administration approved Wegovy, a higher-dose version of the diabetes drug Semaglutide from Novo Nordisk.
In company-funded studies, participants who took Wegovy had an average weight loss of 15%, about 15.3 kilograms. Participants steadily lost weight for 16 months before reaching a plateau. In a comparison group that received dummy shots, the average weight loss was about 2.5%, or just under 6 pounds.
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“With existing medication, you will lose maybe 5 to 10% weight loss, sometimes not even that,” said Dr. Harold Bays, medical director of the Louisville Metabolic and Atherosclerosis Research Center. Bays, who is also the chief science officer of the Obesity Medicine Association, helped conduct studies on Wegovy and other drugs for obesity and diabetes.
In the United States, more than 100 million adults – about one in three – are obese.
Losing as little as 5% weight can bring health benefits such as improved energy, blood pressure, blood sugar and cholesterol levels, but it often doesn’t satisfy patients focused on weight loss, Bays said.
Bays said Wegovy appears to be far safer than previous obesity drugs that “went up in flames” because of safety issues. The most common side effects with Wegovy were nausea, diarrhea, and vomiting. These usually subsided, but led to around 5% of the study participants stopping taking it.
The drug should also not be given to people at risk for some types of cancer, as there is a potential risk of certain thyroid tumors, the FDA said.
Patients inject Wegovy (pronounced wee-GOH’-vee) under their skin every week. Like other weight loss drugs, it should be used in conjunction with exercise, a healthy diet, and other steps such as keeping a food diary.
Novo Nordisk sells two versions of semaglutide for controlling blood sugar levels in type 2 diabetics: a daily pill called Rybelsus and Ozempic, which patients inject weekly. The Danish company didn’t disclose Wegovy’s list price, but Ozempic typically costs $ 850 or more per month with no insurance.
Wegovy builds on a trend where manufacturers of relatively new diabetes drugs are testing them to treat other conditions common to diabetics. For example, Novo Nordisk’s popular diabetes drugs Jardiance and Victoza now have approvals to reduce the risk of heart attack, stroke and death in heart patients.
Phylander Pannell, 49, of Largo, Maryland, participated in a patient study after losing cycles and then regaining weight. She said she received Wegovy, exercised several times a week, and lost 65 pounds over 16 months.
“It helped me curb my appetite and helped me feel full faster,” said Pannell. “It put me on the right track.”
Shortly after she finished college and stopped receiving Wegovy, she took back about half the weight. Since then, she’s lost a lot of it, started taking physical education classes, and bought exercise bikes. She is considering reinstating Wegovy after it is approved.
Wegovy is a synthesized version of an intestinal hormone that curbs appetite. That’s a new strategy in obesity treatment, said Dr. Robert Kushner, Novo Nordisk Medical Advisory Board member who directs Northwestern Medicine’s Lifestyle Medicine Center.
Novo Nordisk is also developing a pill version that should begin final patient studies later this year.
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Follow Linda A. Johnson at https://twitter.com/LindaJ_onPharma.
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The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
