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The indication makes the Novo Nordisk product the first weekly injection GLP-1 agonist approved for managing overweight and obesity.
The US Food and Drug Administration (FDA) has approved semaglutide (Wegovy) once-weekly injection for chronic weight management in adults with obesity or overweight status and at least 1 other weight-related condition.
The new indication for the Novo Nordisk GLP-1 receptor agonist, provided in combination with reduced-calorie diet and physical activity, is the first granted to an agent for chronic weight management in this population since 2014.
The 2.4 mg once-weekly injection semaglutide is just the latest iteration of the agent approved for treatment of conditions pertaining to cardiometabolic disease including hypertension and diabetes.
In January 2020, semaglutide injection (Ozempic) was approved for the reduced risk of major adverse cardiovascular events (MACE) in patients with type 2 diabetes (T2D) and known heart disease.
In September 2019, an oral form of the therapy (Rybelsus) was approved for the treatment of T2D.
In December 2017, Ozempic was approved as an adjunct glycemic control therapy in adults with T2D.
This newest indication, however, makes semaglutide the first GLP-1 agonist approved for weight management in obese persons. Its approval was based on findings from the phase 3A STEP clinical trial program.
In the largest placebo-controlled trial of the program, investigators observed the drug’s efficacy in adults without diabetes who suffered from obesity. Mean patient age at baseline was 46 years old; 74% of all patients were female. Mean body weight was 231 pounds, and average body mass index (BMI) was 38 kg/m2.
Patients treated with semaglutide reported a mean 12.4% reduction in initial bodyweight versus those administered placebo.
Another trial included adults with type 2 diabetes. Mean patient age was 55 years and 51% were female. Mean body weight was 220 pounds and average BMI was 36 kg/m2. Treated patients reported a 6.2% mean reduction of initial body weight versus placebo.
Common adverse events with semaglutdie included nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, etc., in patients with T2D. Among patients without diabetes, common adverse events included flatulence, gastroenteritis, and gastroesophageal reflux disease (GERD).
Wegovy will contain a boxed warning regarding risk of thyroid C-cell tumors associated with treatment. Clinicians are advised to not prescribe the drug to patients with a personal or familial history of medullary thyroid carcinoma, or patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
In a statement accompanying the decision, Novo Nordisk Executive Vice President of Development, Martin Host Lange called the newest semaglutide indication a bringer of “great promise” to the obese patient population.
“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,” Lange said. “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.”