Danish pharmaceutical company Novo Nordisk A/S (NVO) Friday announced the submission of a Marketing Authorisation Application to the European Medicines Agency or EMA for subcutaneous semaglutide 2.4 mg, a once-weekly glucagon-like peptide-1 (GLP-1) analogue for weight management.
The potential indication is for the treatment of adults with obesity or overweight with at least one weight-related comorbidity, as an adjunct to reduced-calorie diet and increased physical activity.
It induces weight loss by reducing hunger, increasing feelings of fullness and thereby helping people eat less and reduce their calorie intake.
The submission is based on the results from the STEP phase 3a clinical trial programme, which included more than 4,500 adults with obesity or overweight.
Novo Nordisk noted that across the STEP programme, people with obesity treated with once-weekly semaglutide 2.4 mg achieved a statistically significant and superior reduction in body weight compared to placebo.
Across the trials in people without diabetes STEP 1, 3 and 4, a weight loss of 15-18% was reported for people treated with semaglutide 2.4 mg. Furthermore, once-weekly semaglutide 2.4 mg appeared to have a safe and well-tolerated profile. The most common side effects were gastrointestinal and were transient, and mild or moderate in severity.
Mads Krogsgaard Thomsen, executive vice president and chief scientific officer of Novo Nordisk, said, "We are excited about this regulatory filing following the recent regulatory filing with the FDA in the US. It is a milestone for Novo Nordisk but more importantly it represents a new treatment option with the potential to transform the medical management for people living with obesity in Europe."
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