Wegovy recommended for approval for the treatment of obesity by CHMP

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending marketing authorization for Wegovy (once-weekly semaglutide 2.4mg injection), from Danish diabetes care giant Novo Nordisk (NOV: N), chronic weight management in adults with obesity.

Wegovy is intended for chronic weight management in adults living with obesity (initial BMI≥30 kg/m2) or overweight (initial BMI≥27 kg/m2) with at least one weight-related comorbidity such as high blood pressure, heart disease or type 2 diabetes.

The positive CHMP opinion is based on results from the STEP Phase IIIa clinical trial program. Across the trials in people with obesity or overweight without type 2 diabetes, an average weight loss of 17-18% sustained over 68 weeks was reported for those treated with Wegovy. Wegovy demonstrated a safe and well-tolerated profile across the program, with the most common adverse events being gastrointestinal.