The US Food and Drug Administration (FDA) has approved Novo Nordisk's 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 =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.
“Many people with obesity suffer from comorbidities. Saxenda has the potential to help some of these people achieve and maintain a clinically significant weight loss and improve their weight-related comorbidities,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.
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.Novo Nordisk expects to launch Saxenda in the US in the first half of 2015.
Obesity is a disease1that 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 severe cost implications to healthcare systems. In the US, approximately 35 per cent of adults, equivalent to approximately 80 million people, live with obesity.