The FDA approved Novo Nordisk’s injectable semaglutide (Wegovy) for adults with obesity or overweight.
The GLP-1 receptor was approved for chronic weight management in adults with obesity (BMI of 30 or greater) or for adults with overweight (BMI 27 or greater) with at least one weight-related condition, such as high blood pressure, type 2 diabetes, or high cholesterol, used in conjunction with a reduced calorie diet and an exercise regimen.
The once-weekly, injectable medication is approved at a dose of 2.4 mg for this indication.
The approval comes based off the Semaglutide Treatment Effect in People with Obesity (STEP) clinical program. The first trial of the program included nearly 2,000 adults with obesity or overweight with at least one weight-related comorbidity without diabetes at baseline. After 68 weeks of treatment those on semaglutide plus lifestyle intervention lost an average 14.9% of baseline body weight versus 2.4% for those on placebo (treatment difference -12.4%, 95% CI -13.4 to -11.5, P<0.001).
Almost 70% of those on semaglutide plus lifestyle intervention achieved a 10% or more weight loss, and more than half were able to lose 15% of their baseline body weight.
Wegovy will have a boxed warning on the potential risk of thyroid C-cell tumors — as do all agents in the GLP-1 receptor agonist class. The drug should not be used in patients with a personal or family history of medullary thyroid carcinoma or in patients with a rare condition called multiple endocrine neoplasia syndrome type 2 (MEN 2).
The drug should not be used with other GLP-1 receptor agonists, other semaglutide-containing products or other weight loss products, such as prescription or over-the-counter drugs or herbal products. Wegovy has also not been studied in patients with a history of pancreatitis, the FDA said.