Novo Nordisk Gets FDA OK for Obesity Drug Saxenda
Novo Nordisk has received approval from the US Food and Drug Administration (FDA) for its new drug application for Saxenda (liraglutide 3 mg), a once-daily human glucagon-like peptide-1 (GLP-1) analog 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 30 or greater (obesity) or adults with a BMI of 27 or greater (overweight) who have at least one weight-related condition such as hypertension, Type 2 diabetes, or high cholesterol (dyslipidemia).
Saxenda has the same active ingredient (liraglutide) as the company’s Type II diabetes drug, Victoza, but is dosed differently (3 mg compared to 1.8 mg for Victoza). Saxenda, however, 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. Victoza is one of the company’s top-selling drugs with 2013 revenues of DKK 11.6 billion ($2.0 billion).
Novo Nordisk expects to launch Saxenda in the US in the first half of 2015.