Novo Nordisk's Wegovy is First and Only Once-Weekly GLP-1 Agonist Approved for Weight Management

FDA provides a green signal to Wegovy. (joreks / Shutterstock) 

The U.S. Food and Drug Administration (FDA) approved Novo Nordisk’s Wegovy for chronic weight management. Wegovy (once-weekly semaglutide 2.4 mg self-injection) is a GLP-1 receptor agonist, a type of drug that is typically used to type 2 diabetes. Wegovy is the first and only once-weekly GLP-1 receptor agonist that’s been approved for weight control in people living with obesity. This is the same drug used to treat type 2 diabetes under the brand name Ozempic, but at a higher dose.

“The approval of Wegovy in the U.S. brings great promise to people with obesity,” said Martin Holst Lange, executive vice president, Development at Denmark’s Novo Nordisk. “Despite the best efforts to lose weight, many people with obesity struggle to achieve and maintain weight loss due to physiological responses that favor weight regain. The unprecedented weight loss for an anti-obesity medication marks a new era in the treatment of obesity, and we now look forward to making Wegovy available to people living with obesity in the U.S.”

Novo Nordisk plans to launch the drug in the U.S. sometime this month. The drug is being reviewed by regulators in the European Union and other countries.

In the STEP Phase IIIa clinical trial program, people who did not have type 2 diabetes lost an average of 17-18% of their weight, which they sustained over 68 weeks. This came, on average, to around 34 pounds. They typically lost weight steadily for 16 months before hitting a plateau. In a placebo group, the average weight loss was just under six pounds, or about 2.5%.

“With existing drugs, you’re going to get maybe 5% to 10% weight reduction, sometimes not even that,” Harold Bays, medical director of the Louisville Metabolic and Atherosclerosis Research Center, told The Washington Post. Bays is also the Obesity Medicine Association’s chief science officer and helped run some of the Wegovy clinical studies.

Bays added that Wegovy’s safety profile is “far safer” than earlier drugs for obesity that “have gone down in flames” over safety issues. The most common side effects of Wegovy are gastrointestinal problems such as nausea, diarrhea and vomiting. They typically subsided, but did cause about 5% of trial participants to stop taking the drug.

There is also a possible risk for a type of thyroid tumor. As a result, the drug is contraindicated for people with a medical history or family history of certain thyroid and endocrine tumors. There is also a risk of depression and inflammation of the pancreas.

Novo Nordisk hasn’t announced a price for the drug, but has said it will be similar to the price of its Saxenda, an injectable weight loss drug that has been on the market for 11 years. Saxenda runs more than $1300 per month for the uninsured.

Archana Sudhu, head of the diabetes program at Houston Methodist Hospital told The Washington Post that not all health insurance programs cover weight-loss treatments. As a result, she believes Wegovy’s usefulness “all depends on what the price will be.”

However, Sudhu, who has no ties to Novo Nordisk, told The Post she plans to move her obese, type 2 diabetic patients to Wegovy. She pointed out that it makes patients feel full sooner and improves release of insulin in order to control blood glucose levels. It might help patients get motivated to eat healthier and exercise.

Novo Nordisk is also working on a pill formulation of the drug.