The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has adopted a positive opinion for the use of Saxenda ( Liraglutide 3 mg ) for the treatment of obesity.

Saxenda is a once-daily glucagon-like peptide-1 ( GLP-1 ) analogue, with 97% homology to naturally occurring human GLP-1, a hormone involved in appetite regulation.

The CHMP positive opinion recommends that Saxenda 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 greater than or equal to 30 kg/m2 ( obese ), or greater than or equal to 27 kg/m² to less than 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.

The CHMP positive opinion is based on data from clinical trials of Saxenda, including the phase 3 SCALE clinical development programme, which involved more than 5,000 people with obesity ( BMI greater than 30 kg/m2 ), or who were overweight ( BMI greater than or equal to 27 kg/m2 ) with comorbidities.

Obesity is a disease that requires chronic management. It is associated with serious comorbidities including type 2 diabetes mellitus, heart disease, obstructive sleep apnoea ( OSA ), certain types of cancer and a decreased life expectancy.
The risk of morbidity and mortality increases with the severity of obesity.
Obesity is a complex and multi-factorial disease that is influenced by genetic, physiological, environmental and psychological factors.

The global increase in the prevalence of obesity is a public health issue that has significant cost implications to healthcare systems. In the EU ( European Union ), obesity affects approximately 10–30% of adults.

Saxenda is involved in appetite regulation and lowers body weight through decreased food intake. Saxenda does not increase 24-hour energy expenditure. Furthermore, Saxenda plays an important role in maintaining a normal level of glucose in the blood in adults with obesity by stimulating the release of insulin and suppressing the release of glucagon in a glucose-dependent manner, when needed.

Saxenda was evaluated in the SCALE ( Satiety and Clinical Adiposity - Liraglutide Evidence in Non-diabetic and Diabetic people ) phase 3 clinical trial programme, which involved more than 5,000 people with obesity ( BMI greater than or equal to 30 kg/m2 ) or who were overweight ( BMI greater than or equal to 27 kg/m2 ) with at least one weight-related comorbidity. ( Xagena )

Source: Novo Nordisk, 2015

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