The FDA has approved Novo Nordisk’s Wegovy (the brand name for once-weekly semaglutide 2.4mg injection in the US) for chronic weight management. Wegovy is indicated as an adjunct to diet and exercise for chronic weight management in adults with obesity (initial BMI≥30 kg/m2) or overweight (initial BMI≥27 kg/m2) with at least one weight-related comorbidity.
“The approval of Wegovy offers adults with obesity or overweight a beneficial new treatment option to incorporate into a weight management program,” said Dr John Sharretts, deputy director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research. “FDA remains committed to facilitating the development and approval of additional safe and effective therapies for adults with obesity or overweight.”
According to the company, Wegovy is the first and only once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist therapy approved for weight management for people living with obesity. The approval is based on the results from the STEP phase 3a clinical trial programme. Across the trials in people without type 2 diabetes, an average weight loss of 17-18% sustained over 68 weeks was reported for people with obesity treated with Wegovy. Wegovy demonstrated a safe and well-tolerated profile across the programme, with the most common adverse events being gastrointestinal.
Wegovy works by mimicking the GLP-1 hormone that targets areas of the brain that regulate appetite and food intake. The medication dose must be increased gradually over 16 to 20 weeks to 2.4mg once weekly to reduce gastrointestinal side effects. Wegovy should not be used in combination with other semaglutide-containing products, other GLP-1 receptor agonists, or other products intended for weight loss, including prescription drugs, over-the-counter drugs, or herbal products. Wegovy has not been studied in patients with a history of pancreatitis.
Wegovy’s safety and efficacy were studied in four 68-week trials. Three were randomised, double-blind, placebo-controlled trials (including 16 weeks of dose increases) and one was a double-blind, placebo-controlled, randomized withdrawal trial in which patients receiving Wegovy either continued with the treatment or switched to a placebo. More than 2,600 patients received Wegovy for up to 68 weeks in these four studies and more than 1,500 patients received placebo.
The largest placebo-controlled trial enrolled adults without diabetes. The average age at the start of the trial was 46 years and 74% of patients were female. The average body weight was 231lbs (105kg) and average BMI was 38 kg/m2. Individuals who received Wegovy lost an average of 12.4% of their initial body weight compared to individuals who received placebo.
In another trial enrolled adults with type 2 diabetes, the average age was 55 years and 51% were female. The average body weight was 220lbs (100kg) and average BMI was 36 kg/m2. In this trial, individuals who received Wegovy lost 6.2% of their initial body weight compared to those who received placebo.
The most common side effects of Wegovy include nausea, diarrhoea, vomiting, constipation, abdominal (stomach) pain, headache, fatigue, dyspepsia (indigestion), dizziness, abdominal distension, eructation (belching), hypoglycaemia (low blood sugar) in patients with type 2 diabetes, flatulence, gastroenteritis (an intestinal infection) and gastroesophageal reflux disease.
“The FDA granted the approval to Novo Nordisk. Semaglutide 1 mg injection (Ozempic) was first approved as a treatment for type 2 diabetes in 2017. 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 favour weight regain,” said Martin Holst Lange, executive vice president, Development at Novo Nordisk. “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.”