The FDA recently approved the novel weight management drug semaglutide for chronic weight management in adults with overweight or obesity, the agency announced in a statement.

Semaglutide is an injectable medication and is approved for chronic weight management in adults with overweight or obesity and at least one associated condition, such as type 2 diabetes or high blood pressure. It is the first weight-management drug to gain FDA approval since 2014, according to the agency.

“Today’s approval offers adults with obesity or overweight a beneficial new treatment option to incorporate into a weight management program,” John Sharretts, MD, deputy director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, said in the press release. “FDA remains committed to facilitating the development and approval of additional safe and effective therapies for adults with obesity or overweight.”

Semaglutide mimics the hormone glucagon-like peptide-1 (GLP-1), which helps regulate the patient’s appetite and food intake. It is administered in a once-weekly dose of 2.4 milligrams. Dosage must be scaled up over the course of 16 to 20 weeks to minimize gastrointestinal side effects. The announcement from the FDA said the drug is meant to be used in conjunction with increased exercise and a reduced-calorie diet.

Researchers studied the drug in three phase 3 trials and one withdrawal trial, which included a total of about 4,500 adults with overweight or obesity. In the largest of these studies, which consisted mostly of women (74%) and excluded patients with diabetes, patients began with a mean weight of 231 pounds and a mean BMI of 38 kg/m². Those assigned to semaglutide lost, on average, 12.4% of their body weight compared with those assigned to placebo. In a study that included patients with type 2 diabetes, participants began with a mean weight of 220 pounds and a BMI of 36 kg/m²; those assigned to semaglutide lost 6.2% of their baseline weight compared to the placebo group.

The drug comes with numerous common side effects, many of them gastrointestinal: abdominal pain, vomiting and/or nausea, diarrhea, constipation, gastroesophageal reflux disease, flatulence, belching, indigestion, abdominal distension, fatigue, headache, dizziness, gastroenteritis and hypoglycemia in patients with type 2 diabetes. The medication also includes a box warning regarding the risk for thyroid C-cell tumors. 

Further, semaglutide comes with warnings for suicidal thinking or behavior, pancreatitis, gallbladder problems such as gallstones, diabetic retinopathy, raised heart rate, hypoglycemia and acute kidney injury.

“The approval of Wegovy in the U.S. brings great promise to people with obesity. Despite the best efforts to lose weight, many people with obesity struggle to achieve and maintain weight loss due to physiological responses that favour weight regain,” Martin Holst Lange, executive vice president of development at Novo Nordisk, said in a statement released by the drug company. “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.”

The drug is expected to launch in late June in the United States, and is under regulatory review in the European Union and various other nations, Novo Nordisk said.

Disclosures: Lange is an employee of Novo Nordisk.