FDA Approves Semaglutide 2.4 mg for Chronic Weight Management in Obesity, Overweight

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The FDA on June 4, 2021, announced approval of semaglutide 2.4 mg injection (Wegovy,™ Novo Nordisk) for chronic weight management in patients with obesity or overweight with at least one weight-related comorbidity, making it the first drug to receive such an approval since 2014.

Semaglutide 2.4 mg is also the first once-weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA) to receive FDA approval for chronic weight management. Specifically, the approved indication is as an adjunct to diet and exercise for chronic weight management in adults with obesity (BMI≥30 kg/m²) or overweight (BMI≥27 kg/m²) with at least one weight-related comorbidity (eg, hypertension, hyperlipidemia, type 2 diabetes [T2D]).

“Today’s approval offers adults with obesity or overweight a beneficial new treatment option to incorporate into a weight management program,” said John Sharretts, MD, deputy director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research in the agency statement.

FDA approval is based on results from the phase 3a STEP clinical trial program which studied the effect of gradually titrated doses of semaglutide over 16 to 20 weeks to a therapeutic dose of 2.4 mg. A lower dose (1 mg) of the GLP-1 RA was first approved as a treatment for T2D in 2017.

STEP program studies were conducted in patients with and without T2D with the largest enrolling those without. Across all studies, use of semaglutide 2.4 mg among those without diabetes was associated with an average weight loss of 17-18% that was sustained over 68 weeks. In the study of patients free of T2D, the average weight at baseline was 231 lbs and average BMI was 38 kg/m². Average age across studies was 50.5 years and the majority of participants were women.

The most common adverse events were gastrointestinal and common to the GLP-1 RA class. Approved labeling for semaglutide 2.4 mg includes a boxed warning regarding the potential risk of thyroid C-cell tumors and contraindicates use in patients with a personal or family history of medullary thyroid carcinoma or in patients with multiple endocrine neoplasia syndrome type 2.

Use of semaglutide 2.4 mg also is contraindicated in combination with other semaglutide-containing products, other GLP-1 RAs or other products intended for weight loss, either prescription or over-the counter.

“The approval of Wegovy in the US 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 favor weight regain,” said Martin Holst Lange, executive vice president, Development at Novo Nordisk in a company statement.

“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.”

The company expects a US launch for semaglutide 2.4 mg later this month.