FDA approves obesity drug that helped people lose weight by 15%

Regulators said a new version of a popular diabetes drug could be sold on Friday in the U.S.

The Food and Drug Administration approved Wegovy, a higher-dose version of Novo Nordisk diabetes drugs semi-swallowed, long-term weight management.

In company-funded studies, participants taking Wegovy had an average weight loss of 15%, about 15.3 kilograms. Participants lost weight consistently for 14 months before the plateau. In a comparison group that received fictitious shots, the average weight loss was about 2.5%, or just under 6 pounds.

“With existing medications, you’ll get maybe 5% to 10% weight reduction, sometimes not even that,” Dr. Harold Bays, medical director of the Louisville Center for Metabolic Research and Atherosclerosis. Bays, who is also the scientific head of the Obesity Medicine Association, helped conduct studies on the drug.

In the United States, more than 100 million adults (about 1 in 3) are obese.

Falling even 5% of your weight can lead to it health benefits, such as energy improvement, blood pressure, blood sugar i cholesterol levels, but that amount often doesn’t satisfy patients who focus on weight loss, Bays said.

Bays said Wegovy seems much safer than previous obesity drugs that have “fallen into flames” due to safety concerns. The most common side effects of Wegovy were gastrointestinal problems, including nausea, diarrhea, and vomiting. Those used to decrease, but caused approximately 5% of study participants to stop taking it.

The drug has a potential risk for one type of thyroid tumor, so it should not be taken by people with 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 an intestinal hormone that slows down appetite. Patients are injected 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 has not disclosed the price of Wegovy, but said it will be similar to the price of its Saxenda, a weight loss drug that is injected daily and now usually costs more than $ 1,300 a month without insurance. .

Dr. Archana Sadhu, head of the diabetes program at Houston Methodist Hospital, said Wegovy’s usefulness “all depends on the price it will have.” He noted that patients ’health insurance plans do not cover weight loss treatments at any time, which puts expensive drugs out of reach.

Sadhu, who has no connection to Novo Nordisk, plans to switch patients who are obese and have type 2 diabetes to Wegovy. It made patients feel full sooner and increased the release of insulin from the pancreas to control blood sugar. Patients would be more likely to be motivated to exercise and eat healthier, he added.

Wegovy starts from a trend in which relatively new manufacturers of diabetes drugs put them to the test to treat other common conditions in diabetics. For example, Novo Nordisk’s popular Jardiance and Victoza diabetes medications 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 cycles of weight loss and recovery. He said he received Wegovy, worked several times a week and lost £ 65 for 16 months.

“It helped me curb my appetite and it helped me feel completely faster,” Pannell said. “It led me down the right path.”

Shortly after finishing the study and stopping receiving Wegovy, he regained about half his weight. He has since lost much of that, started exercise classes and bought exercise equipment at home. He plans to return to Wegovy after approving it.

Novo Nordisk is also developing a tablet version.

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