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Bagsværd, Denmark December 18, 2020 – Novo Nordisk today announced the submission of a Marketing Authorization (AMM) application to the European Medicines Agency (EMA) for subcutaneous semaglutide 2.4 mg, a peptide analogue Glucagon-like 1 (GLP-1) once a week for weight management. The potential indication is the treatment of adults who are obese (BMI ≥ 30 kg / m2) or overweight (BMI ≥ 27 kg / m2) with at least one weight-related comorbidity, in addition to a low-calorie diet and activity increased physique. .
The submission is based on the results of the STEP phase 3a clinical trial program, which included more than 4,500 adults with obesity or overweight. Throughout the STEP program, obese people treated with semaglutide 2.4 mg once weekly achieved a statistically significant and greater reduction in body weight compared to placebo. In trials in people without STEP 1, 3 and 4 without diabetes, weight loss of 15-18% has been reported in people treated with semaglutide 2.4 mg. Additionally, semaglutide 2.4 mg once weekly appears to have a safe and well tolerated profile. The most common side effects were gastrointestinal and were transient and mild to moderate in intensity.
“We are delighted with this regulatory filing following the recent regulatory filing with the FDA in the United States,” said Mads Krogsgaard Thomsen, Executive Vice President and Chief Scientific Officer of Novo Nordisk. “This is an important step for Novo Nordisk but, more importantly, it represents a new treatment option with the potential to transform the medical care of people with obesity in Europe.”
About Obesity and Subcutaneous Semaglutide 2.4 mg for Weight Management
Obesity is a chronic disease that requires long-term management. It is associated with many serious health consequences and reduced life expectancy. Complications from obesity are numerous and include type 2 diabetes, heart disease, obstructive sleep apnea, nonalcoholic fatty liver disease, and cancer.
Novo Nordisk is currently studying 2.4 mg subcutaneous semaglutide once a week as a potential treatment for obesity. Semaglutide is an analogue of the human glucagon-like peptide 1 (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.
For more information on the FDA filing for Semaglutide 2.4 mg, please read the company’s announcement here
About the STEP clinical program
STEP (Semaglutide Treatment Effect in People with Obesity) is a phase 3 clinical development program with 2.4 mg of semaglutide subcutaneously once a week in obesity. The global phase 3a program consists of four trials and has recruited approximately 4,500 adults suffering from overweight or obesity.
STEP 1 – A 68 week safety and efficacy trial of 2.4 mg subcutaneous semaglutide versus placebo in 1,961 obese or overweight adults. For more information, please read the company announcement here
STEP 2 – A 68-week safety and efficacy trial of subcutaneous semaglutide 2.4 mg versus placebo and subcutaneous semaglutide 1 mg once weekly in 1210 adults with type 2 diabetes and obesity or overweight. For more information, please read the company announcement here
STEP 3 – A 68-week safety and efficacy trial of subcutaneous semaglutide 2.4 mg versus placebo in combination with intensive behavioral therapy in 611 obese or overweight adults. For more information, please read the company announcement here
STEP 4 – A 68-week safety and efficacy trial of subcutaneous semaglutide 2.4 mg versus placebo in 803 obese or overweight adults who reached the target dose of 2.4 mg after 20 weeks break-in . For more information, please read the company announcement here
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 making pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs approximately 44,000 people in 80 countries and markets its products in approximately 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.
Further information
Company announcement n ° 78/2020
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PR201218_semaglutide_obesity_EMA_submission
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