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.
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.
For more information call (800) 727-6500 or visit Saxenda.com.