- The FDA has approved the medication Wegovy, a higher dose of the diabetes drug semaglutide, to be used as a weight management drug in patients with obesity.
- In clinical trials, participants without diabetes who took Wegovy lost an average of 12.4 percent of their initial body weight.
- The drug is a synthetic version of a gut hormone that suppresses hunger and appetite.
A diabetes drug has received approval from the Food and Drug Administration (FDA) to also be used as a weight-loss medication in patients with obesity.
The medication, Wegovy, is a higher dose of the diabetes drug semaglutide produced by Novo Nordisk.
It’s the first drug for chronic weight management that has been approved by the FDA since 2014.
Wegovy, administered via a once-weekly injection, is indicated for people with a body mass index (BMI) of 27 kg/m2 or higher and who have at least one weight-related medical condition such as high blood pressure or high cholesterol. The medication is also for people who have a BMI of 30 kg/m2 or higher.
In the United States, approximately 1 in 3 adults — over 100 million people — have obesity. Treating obesity can improve blood pressure, blood sugar, and cholesterol levels.
“Today’s approval offers adults with obesity or overweight a beneficial new treatment option to incorporate into a weight management program,” Dr. John Sharretts, the deputy director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, said in
Wegovy is a synthetic version of a hormone in the gut, glucagon-like peptide-1, that affects the parts of the brain that control hunger and appetite.
It is injected under the skin once a week.
“It slows emptying of the stomach. It promotes the feeling of fullness (satiety) by acting on the brain, particularly at the level of the hypothalamus,” said Dr. Aleem Kanji, a board-certified endocrinologist and obesity medicine physician with Ethos Endocrinology in Houston.
In clinical trials evaluating the safety and efficacy of Wegovy for weight loss, participants without diabetes who took Wegovy lost, on average, 12.4 percent of their initial body weight compared to those who received a placebo.
In a clinical trial conducted in people with type 2 diabetes, those who took Wegovy lost 6.2 percent of their body weight compared to those who received a placebo.
Those who took Wegovy lost weight steadily for 16 months before plateauing.
Gastrointestinal issues — diarrhea, vomiting, constipation, abdominal pain, indigestion, flatulence — were commonly reported side effects. These side effects typically resolved on their own, but 5 percent of participants stopped taking the medication because of them.
Other participants reported headache, fatigue, and dizziness.
“Individuals with obesity and type 2 diabetes are likely good candidates for the dual benefit of improved blood sugar control and weight loss,” said Kanji.
According to Kanji, data suggests Wegovy has a favorable safety profile compared to
Wegovy should not be used with other drugs used for weight loss or medications that contain semaglutide, according to the FDA.
Wegovy has a potential risk of thyroid C-cell tumors and should also not be given to people with a personal or family history of medullary thyroid carcinoma and Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
The drug has not been studied in people who have a history of pancreatitis.
The drug, at a dose of 1 mg, was first approved for type 2 diabetes in 2017.
Kanji plans to add Wegovy as a treatment option for certain patients with obesity — especially those with type 2 diabetes.
The price is expected to be similar to Saxenda, which costs $1,349 a month without insurance.
“As is often the case, cost and health insurance coverage will be the limiting factor,” said Kanji.
The Food and Drug Administration has approved the diabetes drug semaglutide to be used as a weight-loss medication in patients with obesity. The drug is a synthetic version of a gut hormone that suppresses hunger and appetite. In clinical trials, participants who took the medication lost about 12 percent of their body weight compared to those who took a placebo. This is the first drug the FDA has approved for weight loss since 2014.