Novo Nordisk announced that the Food and Drug Administration (FDA) has approved a labeling update for Saxenda (liraglutide) injection to include long-term safety and efficacy data from the SCALE trial.
The SCALE (Satiety and Clinical Adiposity – Liraglutide Evidence in adults with and without Diabetes) Obesity and Pre-diabetes trial was a 3-year trial that evaluated the long-term safety and efficacy of Saxenda in combination with a reduced-calorie meal plan and increased physical activity, in adults with pre-diabetes at screening. Study patients were obese ( BMI ≥30kg/m2) or overweight (BMI ≥27kg/m2) with ≥1 weight-related comorbidity, and on a reduced-calorie meal plan with increased physical activity.
A total of 3,731 patients were treated for 56 weeks; those with pre-diabetes were treated for 160 weeks. The study aimed to assess the maintenance of weight loss (≥5% of body weight). In the study, almost half of the Saxenda-treated patients (26% vs. 10% placebo) who lost ≥5% of body weight after 56 weeks (56% vs. 25% placebo) maintained their weight loss for 3 years.
These findings further confirm the safety profile of Saxenda and are comparable to the safety data seen at 56 weeks. Gastrointestinal adverse events (eg, nausea, diarrhea) were more common with Saxenda vs. placebo.
Saxenda, a once-daily glucagon-like peptide-1 (GLP-1) receptor agonist, is indicated 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 of ≥30kg/m2 or ≥27kg/m2 in the presence of at least one weight-related comorbid condition. It is available as a solution for subcutaneous injection in a pre-filled, multi-dose pen.
For more information call (800) 727-6500 or visit Saxenda.com.