Novo Nordisk’s obesity drug Saxenda approved by FDA

Continuing its rush of year-end drug approvals, the US Food and Drug Administration late yesterday approved Danish diabetes care giant Novo Nordisk’s (NOV: N) New Drug Application for Saxenda (liraglutide 3mg), 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 a body mass index (BMI) of 30kg/m2 or greater (obesity) or who are overweight (BMI 27kg/m2) with at least one weight-related co-morbidity such as type 2 diabetes and cardiovascular disease. The active ingredient liraglutide is already marketed at a lower dosage for the treatment of diabetes as Victoza and has reached blockbuster status in that indication

"Many people with obesity suffer from co-morbidities. Saxenda has the potential to help some of these people achieve and maintain a clinically significant weight loss and improve their weight-related co-morbidities," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.

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