Wegovy (semaglutide 2.4 mg), the first and only once-weekly GLP-1 therapy for weight management, approved in the US
Bagsværd, Denmark, 4 June 2021 – Novo Nordisk today announced that the US Food
and Drug Administration (FDA) has approved Wegovy (the brand name for once-weekly semaglutide 2.4 mg 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.
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%1 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.
“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 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”.
Novo Nordisk expects to launch WegovyTM in the United States later in June 2021.
Conference call
On 7 June at 8.30 CEST, corresponding to 2.30 am EDT, a conference call for investors will be held. Investors will be able to listen in via a link on the investor section of novonordisk.com.
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About obesity
Obesity is a chronic disease that requires long-term management. It is associated with many serious health complications and decreased life expectancy. Obesity-related complications are numerous
and include type 2 diabetes, heart disease, obstructive sleep apnoea, non-alcoholic fatty liver disease and certain types of cancer. The current COVID-19 pandemic has highlighted that obesity also
increases the risk for severe illness and hospitalisation due to COVID-19.