A new version of a popular diabetes drug could be sold as a weight-loss drug in the US, regulators say. The Food and Drug Administration approved Wegovy on Friday.
Regulators said on Friday that a new version of a popular diabetes drug could be marketed as a weight-loss drug in the US.
The Food and Drug Administration approved Wegovy, a high-dose version of Novo Nordisk’s diabetes drug semaglutide.
In the company-funded studies, the average weight gain of 15% of participants taking Wegovi was about 34 pounds (15.3 kg). Participants consistently lost weight for 16 months before plateauing. In a comparison group that received dummy shots, the average weight loss was about 2.5%, or just under 6 pounds.
“With current medications, you’ll probably get about 5% to 10% of your weight loss, sometimes not even that,” said Dr. Harold Baez, MD, medical director of the Louisville Metabolic and Atherosclerosis Research Center. Baez, who is also chief science officer for the Obesity Medicine Association, helped run the study of Wegovi and other obesity and diabetes drugs.
In the US, more than 100 million adults — about one in three — are obese.
Baez said that dropping even 5% of one’s weight can have health benefits, such as improved energy, blood pressure, blood sugar and cholesterol levels, but it often doesn’t satisfy patients who focus on weight loss. Huh.
Baez said Wegovi appears to be far safer than earlier obesity drugs that “have gone up in flames” over safety problems. The most common side effects of Wegovy were nausea, diarrhea, and vomiting. They usually subsided, but about 5% of study participants stopped taking it.
The FDA said the drug should also not be given to people at risk for certain cancers, because of the potential risk of certain thyroid tumors.
Patients inject WeGovy (pronounced wee-goh-vee) weekly under their skin. Like other weight loss medicines, it should be used in conjunction with exercise, a healthy diet, and other steps such as keeping a food diary.
Novo Nordisk sells two semaglutide versions to control blood sugar in type 2 diabetics: a daily pill called RaeBelsus and Ozempic, which patients inject weekly. The Danish company didn’t disclose Wegovi’s list price, but Ozempic typically costs $850 or more per month without insurance.
Wegovy draws on a trend in which manufacturers 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 are now approved to reduce the risk of heart attack, stroke and death in heart patients.
Philander Panell, 49, of Largo, Maryland, joined a patient study following a cycle of losing and then gaining weight. She said she gained Wegovy, worked out several times a week, and lost 65 pounds in 16 months.
“It helped curb my appetite and it helped me feel full faster,” Pannell said. “It got me on the right track.”
Shortly after she finished the study and stopped receiving Wegovi, she regained about half the weight. She has since lost a lot, starting exercise classes and buying home exercise equipment. She is considering going back to Wegovy once approved.
Wegovi is a synthesized version of a gut hormone which reduces appetite. This is a new strategy in the treatment of obesity, said Dr. Robert Kushner, a member of the medical advisory board of Novo Nordisk, head of Northwestern Medicine’s Center for Lifestyle Medicine.
Novo Nordisk is also developing a pill version that should begin final patient studies later this year.
Follow Linda A. Johnson at https://twitter.com/LindaJ—onPharma.
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