Bagsværd, FrommMark, 4 June 2021 – Novo Nordisk today announced that the United States Food and Drug Administration (FDA) has approved Wegovy ™ (the brand name for the weekly injection of 2.4 mg of semaglutide in the United States) for management chronic weight. Wegovy ™ is indicated as a supplement to diet and exercise for chronic weight management in obese adults (baseline 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 treatment approved for weight management in people with obesity. The approval is based on the results of the STEP phase 3a clinical trial program. In trials in people without type 2 diabetes, an average weight loss of 17-18%1 for more than 68 weeks has been reported in obese people treated with Wegovy ™. Wegovy ™ has demonstrated a safe and well tolerated profile throughout the program, with the most common adverse events being gastrointestinal.
“The approval of Wegovy ™ in the United States holds great promise for obese people. Despite the best efforts to lose weight, many obese people struggle to achieve and maintain weight loss due to physiological responses that promote weight gain, ”said Martin Holst Lange, Executive Vice President, Development at Novo Nordisk. “The unprecedented weight loss for an anti-obesity drug marks a new era in the treatment of obesity, and we now look forward to making Wegovy ™ available to people with obesity in the United States.”
Novo Nordisk plans to launch WegovyMT in the United States later in June 2021.
On June 7 at 8:30 am CEST, corresponding to 2:30 am EDT, an investor conference call will take place. Investors will be able to listen via a link on the investors section of novonordisk.com.
Obesity is a chronic disease that requires long-term management. It is associated with many serious health complications and reduced life expectancy. Complications from obesity are numerous and include type 2 diabetes, heart disease, obstructive sleep apnea, nonalcoholic fatty liver disease, and certain types of cancer. The current COVID-19 pandemic has highlighted that obesity also increases the risk of serious illness and hospitalization from COVID-19.
The global increase in the prevalence of obesity is a public health problem with serious cost implications for health systems. It is estimated that around 650 million adults live with obesity worldwide.
About Wegovy ™ (semaglutid 2.4 mg) and STEP
Semaglutide 2.4 mg is a GLP-1 receptor agonist, with 94% similarity to the naturally occurring human GLP-1 hormone. It induces weight loss by reducing hunger, increasing feelings of fullness and thus helping people eat less and reduce their calorie intake. Semaglutide 2.4 mg weekly injection is approved for the treatment of adults with obesity or overweight in the United States, in addition to diet and exercise.
Semaglutide 2.4 mg for weight management is currently under regulatory review in the EU and other countries. Submissions are based on the results of the Phase 3 clinical development program STEP (Semaglutide Treatment Effect in People with Obesity). The global Phase 3a clinical program consists of four trials and has recruited approximately 4,500 overweight or obese adults.
About Novo Nordisk
Novo Nordisk is a leading global healthcare company, founded in 1923 and based in Denmark. Our goal is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do this by innovating in scientific breakthroughs, expanding access to our medicines, and working to prevent and cure disease. Novo Nordisk employs approximately 45,800 people in 80 countries and markets its products in around 170 countries. Novo Nordisk B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information visit novonordisk.com, Facebook, Twitter, LinkedIn, Youtube.
Company announcement n ° 38/2021
1 Based on the estimate of the test product (secondary statistical approach): effect of treatment if all people adhered to treatment and did not initiate other anti-obesity therapies. When using a treatment policy estimate, weight loss of 15-17% has been reported.