FDA Approves Prescription Weight Loss Therapy for Adults With Obesity

Officials with the FDA have approved the new drug application (NDA) for semaglutide injection (Wegovy; Novo Nordisk) 2.4 mg for adults with obesity (BMI ≥30) or overweight BMI ≥27). According to Novo Nordisk, this novel drug is the only prescription weight-loss medication with once-weekly dosing.

Semaglutide injection is indicated for use with a reduced calorie meal plan and increased physical activity to help adults with obesity or overweight, who also have weight-related medical problems, lose weight and maintain weight loss.

According to Novo Nordisk, obesity is associated with 60 or more other serious health conditions, as well as decreased life expectancy. Approximately 42% of adults in the United States live with obesity, which has many contributing factors, including genetics, lifestyle, and environment.

Obesity is recognized as a chronic disease and health issue by leading health organizations, including the American Medical Association, the CDC, The Obesity Society, and the World Obesity Federation, among other international organizations.

The approval of semaglutide injection was based on the results of the STEP (Semaglutide Treatment Effect in People with Obesity) clinical trial program, which included 4 phase 3a clinical trials with approximately 4500 patients overall. These trials demonstrated that patients receiving semaglutide injection achieved a significant reduction in body weight compared with placebo. Both groups had used a reduced calorie meal plan and increased physical activity.

In the STEP 1 trial, results also showed that patients taking semaglutide injection achieved an average weight loss of 14.9% of body weight at 68 weeks compared with 2.4% body weight loss for placebo. In addition, 83.5% of patients achieved 5% or more body weight reduction in the semaglutide injection arm compared with 31.1% for placebo.

"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, nonsurgical option with results that have never been demonstrated with an anti-obesity medicine before," said Robert Kushner, MD, professor of medicine and medical education at Northwestern University, Feinberg School of Medicine, Chicago, in a press release. "The approval of [semaglutide injection] represents a turning point for health care providers to embrace medical management of obesity to help improve chronic weight management for patients."

The most frequently reported adverse events were nausea, diarrhea, vomiting, constipation, and abdominal pain, according to Novo Nordisk.

Novo Nordisk expects to launch semaglutide injection in June 2021.

REFERENCE

Novo Nordisk receives FDA approval for Wegovy to treat adults with obesity based on unprecedented efficacy for a prescription medicine in clinical trials [news release]. June 4, 2021; Novo Nordisk. [email]