Novo Nordisk announced that the Food and Drug Administration (FDA) has approved Saxenda (liraglutide [rDNA origin]) injection as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of ≥30kg/m2 (obese) or ≥27kg/m2 (overweight) in the presence of at least one weight-related comorbid condition (eg, hypertension, type 2 diabetes mellitus, or dyslipidemia).

Saxenda is the first glucagon-like peptide-1 (GLP-1) receptor agonist approved for this indication.  Like endogenous GLP-1, liraglutide binds to and activates the GLP-1 receptor, a cell-surface receptor coupled to adenylyl cyclase activation through the stimulatory G-protein, Gs. GLP-1 is a physiological regulator of appetite and calorie intake, and the GLP-1 receptor is present in several areas of the brain involved in appetite regulation. 

The approval of Saxenda was based on the Phase 3 SCALE (Satiety and Clinical Adiposity-Liraglutide Evidence in Non-diabetic and Diabetic adults) program that studied over 5,000 patients who are obese or who are overweight with comorbidities. Study results showed that Saxenda, in combination with a reduced-calorie diet and increased physical activity, led to significantly greater weight loss vs. diet and physical activity alone. 

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Saxenda should not be used in combination with any other drug belonging to the GLP-1 receptor agonist class, including Victoza, a treatment for type 2 diabetes. Saxenda and Victoza contain the same active ingredient (liraglutide) at different doses (3 mg and 1.8 mg, respectively). However, Saxenda is not indicated for the treatment of type 2 diabetes, as the safety and efficacy of Saxenda for the treatment of diabetes has not been established.  

Saxenda injection will be available as prefilled multi-dose pens delivering doses of 0.6mg, 1.2mg, 1.8mg, 2.4mg, or 3mg (6mg/mL, 3mL)  in 3- and 5-count cartons. It is expected to launch in the first half of 2015.

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