Novo Nordisk receives FDA approval for Saxenda®

Novo Nordisk today (Wednesday) announced that the US Food and Drug Administration (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 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, according to a statement.