EMA positive opinion for use of liraglutide for treatment of obesity
The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) adopted a positive opinion for the use of liraglutide 3 mg for the treatment of obesity.
Liraglutide 3 mg, is a once-daily injection of a glucagon-like peptide-1 (GLP-1) analogue, with 97% homology to naturally occurring human GLP-1, a hormone released in response to food intake and involved in appetite regulation. The CHMP positive opinion recommends that liraglutide will be indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of > 30 kg/m2 (obese), or > 27 kg/m² to < 30 kg/m² (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia (pre-diabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia or obstructive sleep apnoea.
De CHMP positive opinion is based on data from clinical trials of liraglutide, including the phase 3 SCALE (Satiety and Clinical Adiposity−Liraglutide Evidence in Non-diabetic and Diabetic people). More patients given liraglutide achieved clinically relevant weight loss than those treated with placebo. All patients enrolled in these trials received counselling on diet and physical activity.
clinical development programme, which involved more than 5000 people with obesity or who were overweight with comorbidities.