FDA Approves Once-Weekly Semaglutide for Chronic Weight Management

The FDA has approved semaglutide 2.4 mg injection (Wegovy; Novo Nordisk) for chronic weight management, making it the first once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist therapy for weight management for individuals living with obesity.

With this approval, semaglutide 2.4 mg is indicated as an adjunct to diet and exercise in adults with obesity (initial body mass index [BMI] ≥ 30 kg/m2) or overweight (initial BMI ≥ 27 kg/m2) with at least 1 weight-related comorbidity. It works to induce weight loss by reducing hunger and increasing feeling of fullness.

In the STEP phase 3a clinical trial program, treatment with semaglutide 2.4 mg resulted in an average weight loss of 17% to 18%, sustained over 68 weeks for individuals with obesity, among individuals without type 2 diabetes.

The STEP 3 clinical trial investigated the effect of once-weekly subcutaneous (sc) semaglutide 2.4 mg after 68 weeks compared with placebo in 611 adults with obesity or overweight with comorbidities. Both treatments were administered in conjunction with intensive behavioral therapy (IBT), defined as weekly behavioral support, dietician counseling, and a reduced calorie diet.

The key findings of the study showed:

• When taken as intended, participants treated with sc semaglutide 2.4 mg plus IBT achieved a weight loss of 17.6% compared with a 5.7% weight loss with placebo plus IBT after the treatment period.
• After 68 weeks, 89.8% of those treated with sc semaglutide plus IBT achieved a weight loss of 5% or more compared with 50.0% with placebo plus IBT.

Across both STEP 2 and STEP 3 trials, sc semaglutide 2.4 mg appeared to have a safe and well-tolerated profile, consistent with previous findings. The most common adverse effects among those treated with sc semaglutide 2.4 mg were gastrointestinal events.

“The approval of Wegovy in the US brings great promise to people with obesity,” said Martin Holst Lange, executive vice president, Development at 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 US.”

Novo Nordisk expects to launch Wegovy in the US later in June 2021, the company said.