The FDA announced on June 4 that it has approved a new indication for the glucagon-like peptide-1 receptor agonist semaglutide (Wegovy), which was first approved to treat type 2 diabetes in 2017.
The once-weekly injection is now approved for chronic weight management in adults with a body mass index (BMI) of 27 kg/m2 or greater who have at least one weight-related condition, such as high blood pressure, type 2 diabetes, or high cholesterol, and those with a BMI of 30 kg/m2 or greater. The treatment should be used in addition to a reduced-calorie diet and increased physical activity, the FDA said. The drug is the first approved medication for chronic weight management in adults with general obesity or overweight since 2014.
Safety and efficacy of the drug for this indication were studied in four 68-week randomized trials, which showed greater weight loss compared to placebo in populations with and without type 2 diabetes. The most common side effects include nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distension, eructation, hypoglycemia in patients with type 2 diabetes, flatulence, gastroenteritis, and gastroesophageal reflux disease. A boxed warning informs clinicians about the potential risk of thyroid C-cell tumors.