Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) approved an updated product label for Saxenda (liraglutide) injection 3 mg, including data showing that approximately half of patients on Saxenda (26% vs 10% on placebo) who lost more than or equal to 5% of their weight after 56 weeks (56% vs 25% on placebo) maintained their weight loss for 3 years. Study participants were adults with obesity (body mass index [BMI] ≥30 kg/m2) or excess weight (BMI ≥27 kg/m2) with at least one weight related comorbidity, on a reduced calorie meal plan and increased physical activity.
"We are pleased by the FDA's approval, which marks Saxenda as the only weight-loss and management medicine in a pen supported by long-term safety and efficacy data,” Dr. Todd Hobbs, vice president and chief medical officer at Novo Nordisk US said. “The addition of this clinical data to the Saxenda label underscores Novo Nordisk's dedication to building a robust body of scientific evidence, highlighting the chronic, progressive nature of the disease of obesity.”
The label update is based on data from the SCALE (Satiety and Clinical Adiposity – Liraglutide Evidence in adults with and without Diabetes) Obesity and Pre-diabetes 3-year trial that investigated the long-term efficacy and safety of Saxenda, in combination with a reduced-calorie meal plan and increased physical activity, in adults with pre-diabetes at screening.
All patients (n=3731) were treated for 56 weeks, and those with pre-diabetes (n=2254) were treated for 160 weeks. Patients were stratified at a 2:1 ratio to Saxenda arm or placebo arm. The study evaluated the maintenance of weight loss of at least 5% of body weight. At 160 weeks, the amount of people with a weight assessment was 50% in the Saxenda arm and 43% in the placebo arm.