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 has approved Wegovy, a higher-dose version of Novo Nordisk’s diabetes drug Semaglutide, for long-term weight loss.
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.
“With existing medication, you may get 5 to 10 percent 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 the drug.
In the US, more than 100 million adults – about 1 in 3 – are obese.
Even a 5% weight loss can bring health benefits such as improved energy, blood pressure, blood sugar and cholesterol levels, but that amount often doesn’t satisfy patients focused on weight loss, Bays said.
Bays said Wegovy appears to be far safer than previous obesity drugs, which “went up in flames” because of safety issues. The most common side effects with Wegovy were gastrointestinal problems, including nausea, diarrhea, and vomiting. These usually subsided, but led to around 5% of the study participants stopping taking it.
The drug carries a potential risk of developing some type of thyroid tumor, so it should not be used by people with a personal or family history of certain thyroid and endocrine tumors. Wegovy is also at risk for depression and pancreatitis.
Wegovy (pronounced wee-GOH’-vee) is a synthesized version of an intestinal hormone that curbs appetite. Patients inject it under the 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.
The Danish company has not disclosed Wegovy’s price, but said it will be similar in price to Saxenda, an 11-year-old weight loss drug that is injected daily and is now typically over $ 1,300 a month with no insurance costs.
Dr. Archana Sudhu, director of the diabetes program at Houston Methodist Hospital, said Wegovy’s usefulness “all depends on what the price will be.” She found that sometimes patients’ health insurance policies do not cover weight loss treatments, which puts expensive drugs out of reach.
Sudhu, who has no affiliation with Novo Nordisk, plans to switch patients with obesity and type 2 diabetes to Wegovy. Patients feel full faster and increase the amount of insulin the pancreas produces to help control blood sugar, she said. Patients would then be more motivated to exercise and eat healthier diets, she added.
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.
Novo Nordisk is also developing a pill version.
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Follow Linda A. Johnson at https://twitter.com/LindaJ_onPharma.
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