Updated on 31 December 2014
Novo Nordisk receives FDA approval for its obesity drug
Novo Nordisk has announced that the US Food and Drug Administration (US FDA) 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 =>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 Mr Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.
Novo Nordisk expects to launch the drug in the US in the first half of 2015.