Saxenda liraglutide 3 mg regulatory update

FDA approved an NDA from Novo Nordisk for 3 mg Saxenda liraglutide as an adjunct to diet and exercise for chronic weight management in adults with a BMI of =30 or in adults with a BMI of =27 with =1 comorbidity, including hypertension, Type II diabetes or dyslipidemia. The approval comes well after Saxenda’s Oct. 20 PDUFA date. The company said it expects to launch the human glucagon-like peptide-1 (GLP-1) analog this half. Saxenda is under review in the EU.

FDA based its approval on 3 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 as Victoza to treat Type II diabetes. ...