Novo Nordisk’s Obesity Drug Wins FDA Approval

Novo Nordisk has received approval from the FDA for its NDA for Saxenda(R) (liraglutide 3mg), the first once-daily human glucagon-like peptide-1 (GLP-1) analogue for the treatment of obesity. Saxenda is indicated as an adjunct to a reduced-calorie diet and exercise for chronic weight management in obese adults (BMI =>30 kg/m2) or who are overweight (BMI =>27 kg/m2) with at least one weight-related comorbidity such as type 2 diabetes and cardiovascular disease.
 
The Phase III SCALE (Satiety and Clinical Adiposity−Liraglutide Evidence in Non-diabetic and Diabetic adults) clinical program included more than 5,000 study participants who have obesity or were overweight with comorbidities.Trial data showed that Saxenda, in combination with a reduced-calorie diet and increased physical activity, resulted in significantly greater weight loss than diet and physical activity alone.