Novo's Saxenda wins FDA approval

FDA approved Saxenda liraglutide from Novo Nordisk A/S (CSE:NVO; NYSE:NVO) for chronic weight management as an adjunct to diet and exercise in obese adults or in overweight adults with at least one co-morbidity. The approval comes well after Saxenda's Oct. 20 PDUFA date.

FDA based its approval on three trials, including studies in which 3 mg doses of the injectable drug led to weight loss in both diabetic and non-diabetic patients. Novo markets 1.2 and 1.8 mg doses of liraglutide, a long-acting analog of glucagon-like peptide-1 (GLP-1), as Victoza to treat Type II diabetes. ...