Cristian Mihaila / AP
Regulators said Friday that a new version of a popular diabetes drug could be marketed as a weight loss drug in the United States
The Food and Drug Administration has approved Wegovy, a higher-dose version of semaglutide for Novo Nordisk diabetes, for long-term weight management.
In company-funded studies, participants taking Wegovy had an average weight loss of 15%, about 15.3 pounds. Participants lost weight steadily for 16 months before laying. In the comparison group receiving the fake injections, the average weight loss was about 2.5%, or just under 6 pounds.
“With existing drugs, you may achieve a reduction of 5% to 10%, sometimes not even that,” said Dr. Harold Bays, medical director of the Research Center for Metabolism and Atherosclerosis in Louisville. Bays, who is also the chief scientific officer of the Association for the Treatment of Obesity, helped conduct the drug study.
In the United States, more than 100 million adults – about 1 in 3 – are obese.
A drop of as much as 5% of one’s weight can bring health benefits, such as improved energy, blood pressure, blood sugar levels and cholesterol, but that amount often does not satisfy patients who are focused on losing weight, Bays said.
Bays said Wegovy seems far safer than earlier obesity medications that “blazed” due to safety concerns. The most common side effects of Wegovy were gastrointestinal problems, including nausea, diarrhea, and vomiting. They usually calmed down, but led to the fact that about 5% of the study participants stopped taking it.
The drug carries a potential risk for the type of thyroid tumor, so it should not be taken by people who have a personal or family history of certain thyroid and endocrine tumors. Wegovy also has a risk of depression and inflammation of the pancreas.
Wegovy (pronounced wee-GOH’-vee) is a synthesized version of the intestinal hormone that suppresses appetite. Patients inject it weekly under the skin. Like other weight loss medications, it should be used in conjunction with exercise, a healthy diet, and other steps such as keeping a food diary.
The Danish company did not announce the price of Wegovy, but said it would be similar to the price of Saxende, an 11-year-old weight loss drug that is injected daily and usually costs more than $ 1,300 a month without insurance.
Dr. Archana Sudhu, head of the diabetes program at Houston Methodist Hospital, said Wegovy’s usefulness “all depends on how much it will cost.” She noted that patients ’health insurance plans sometimes do not cover weight loss treatments, putting expensive medications out of reach.
Sudhu, who has nothing to do with Novo Nordisk, plans to transfer patients who are obese and have type 2 diabetes to Wegovy. Patients seem to feel full sooner and increase the release of insulin from the pancreas to control blood sugar, she said. Then it would be more likely that patients will be motivated to exercise and eat healthier, she added.
Wegovy builds on a trend in which manufacturers of relatively new diabetes drugs are testing them to treat other conditions common to diabetics. For example, Novo Nordisk’s popular Jardiance and Victoza diabetes drugs now have approvals to reduce the risk of heart attack, stroke and death in heart patients.
Phylander Pannell, 49, of Largo, Maryland, joined a study of patients after a cycle of losing and then regaining weight. She said she received Wegovi, worked several times a week and lost 65 pounds over 16 months.
“It helped alleviate my appetite and helped me feel full faster,” Pannell said. “Take me on the right path.”
Shortly after she completed her studies and stopped receiving Wegovy, she regained about half her weight. Since then, she has lost most of it, started exercise classes and bought home exercise equipment. He is considering returning to Wegovy after being approved.
Novo Nordisk is also developing a tablet version.