The FDA ( Food and Drug Administration ) has approved the New Drug Application ( NDA ) for Saxenda ( Liraglutide 3 mg ), 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 increased physical activity for chronic weight management in adults with obesity ( BMI greater than or equal to 30 kg/m2 ) or who are overweight ( BMI greater than or equal to 27 kg/m2 ) with at least one weight-related comorbidity such as type 2 diabetes and cardiovascular disease.
The approval follows the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee ( EMDAC ) meeting on 11 September 2014, which voted 14–1 that the overall risk-benefit of Saxenda was favourable and supported approval for chronic weight management.
Obesity is a disease that requires chronic management. It is associated with serious comorbidities including type 2 diabetes, 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.
It 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 s severe cost implications to healthcare systems. In the US, approximately 35% of adults, equivalent to approximately 80 million people, live with obesity.
Saxenda is a once-daily glucagon-like peptide-1 ( GLP-1) analogue with 97% similarity to naturally occurring human GLP-1, a hormone that is released in response to food intake.
Like human GLP-1, Saxenda regulates appetite and lowers body weight through decreased food intake.
As with other GLP-1 receptor agonists, Liraglutide stimulates insulin secretion and reduces glucagon secretion in a glucose-dependent manner. These effects can lead to a reduction of blood glucose.
Saxenda was evaluated in the SCALE ( Satiety and Clinical Adiposity - Liraglutide Evidence in Nondiabetic 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, 2014