Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved the new drug application (NDA) for Wegovy? (semaglutide) injection 2.4 mg, the first-and-only prescription weight-loss medication with once-weekly dosing. Wegovy? is used with a reduced calorie meal plan and increased physical activity for adults with obesity (BMI ≥30) or overweight (excess weight) (BMI ≥27) who also have weight related medical problems to help them lose weight and keep the weight off.1

Approximately 42% of adults in the US live with obesity, a chronic disease which is recognized by the Centers for Disease Control and Prevention (CDC) as an epidemic.2,3 Obesity is a gateway disease associated with at least 60 other serious health conditions and decreased life expectancy.4,5

The FDA approval of Wegovy was based on the results of the STEP (Semaglutide Treatment Effect in People with Obesity) clinical trial program, which included four phase 3a clinical trials involving approximately 4,500 patients. The trials demonstrated that patients taking Wegovy? with a reduced calorie meal plan and increased physical activity achieved a significant reduction in body weight compared with placebo (reduced calorie meal plan and increased physical activity only). In the STEP 1 trial, results also showed that patients taking Wegovy achieved an average weight loss of 14.9% of body weight at 68-weeks vs. 2.4% for placebo. In addition, 83.5% of patients achieved 5% or more body weight reduction in the Wegovy arm vs. 31.1% for placebo.1 

The most frequently reported adverse events were nausea, diarrhea, vomiting, constipation, and abdominal pain.1

"This is the first time we have seen this magnitude of weight loss with a medicine. This approval gives people with obesity a once-weekly, non-surgical option with results that have never been demonstrated with an anti-obesity medicine before," said Dr. Robert Kushner, professor of medicine and medical education at Northwestern University, Feinberg School of Medicine, Chicago. "The approval of Wegovy represents a turning point for healthcare providers to embrace medical management of obesity to help improve chronic weight management for patients."

"For more than two decades, Novo Nordisk has led the charge to translate the complex science behind obesity into medical health supplies that can make a difference, all while partnering across industries and sectors to change how obesity is understood, diagnosed and treated," said Doug Langa, executive vice president, North America operations and president of Novo Nordisk Inc. "With the unprecedented efficacy of Wegovy and our innovative, industry-leading pipeline, we have the most significant opportunity yet to drive meaningful change for people with obesity, and the providers committed to their health."

Obesity is recognized as a chronic disease and health issue by leading health organizations, including the American Medical Association, Centers for Disease Control and Prevention, The Obesity Society, and the World Obesity Federation, among other global organizations.3,6-8 Obesity has many contributing factors, including genetics, lifestyle and environment.9

"It's remarkable that obesity is still seen as a personal flaw rather than a medical condition requiring treatment, just like any other chronic disease. This disease can negatively impact one's quality of life, both through societal weight bias and stigma, as well as its association with numerous serious health issues," said Joe Nadglowski, president and chief executive officer of the Obesity Action Coalition. "It's time that we recognized this national public health crisis and the need for as many tools as possible to address it. Expanding safe and clinically effective treatment options for obesity management is good news for people with obesity and the medical community."

Novo Nordisk expects to launch Wegovy? later this month.