The Food and Drug Administration (FDA) has approved Saxenda® (liraglutide; Novo Nordisk) as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in patients aged 12 years and older with body weight above 60kg and an initial body mass index (BMI) corresponding to 30kg/m2 or greater for adults (obese). Previously, Saxenda was only approved for chronic weight management in adults.
The approval was based on data from a double-blind, placebo-controlled phase 3 study that evaluated the efficacy and safety of Saxenda in 251 pubertal patients aged 12 to 17 years with BMI corresponding to 30kg/m2 or greater for adults and at the 95th percentile or greater for their age and sex. After a 12-week lifestyle run-in period, patients were randomized 1:1 to receive either Saxenda or placebo once daily for 56 weeks. The primary end point was the change in BMI standard deviation score (BMI SDS).
Results showed that after 56 weeks, patients treated with Saxenda achieved a statistically significant reduction in BMI SDS of -0.23 compared with no reduction in the placebo group (estimated treatment difference: -0.22; 95% CI, -0.37, -0.08; P =.0022). Additionally, patients treated with Saxenda lost an average of 2.65% of their body weight at week 56 compared with those treated with placebo who gained an average of 2.37% of their body weight.
The safety profile of Saxenda in pediatric patients was similar to that seen in adults. The most common adverse reactions reported in the trial included nausea, vomiting, diarrhea, dizziness and fever. The use of Saxenda in pediatric patients with type 2 diabetes mellitus (T2DM) has not been established.
Saxenda carries a Boxed Warning regarding the risk of thyroid c-cell tumors. Patients should also be monitored for pancreatitis, depression and suicidal thoughts, heart rate increase, acute gallbladder disease, and renal impairment.
“New options to treat adolescents who live with obesity can bring much-needed hope to families and help address this growing epidemic,” said Dr. Aaron Kelly, Professor of Pediatrics and co-director of the Center for Pediatric Obesity Medicine at the University of Minnesota. “[…] I’m encouraged that healthcare providers now have another tool in developing a personalized, complete care plan to help adolescents lose weight and keep it off.”
Saxenda, a glucagon-like peptide-1 (GLP-1) receptor agonist, is already indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial BMI of 30kg/m2 or greater (obese), or 27kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (eg, hypertension, T2DM, dyslipidemia).
For more information visit saxenda.com.
1. FDA approves weight management drug for patients aged 12 and older. [press release]. Silver Springs, MD: US Food and Drug Administration; December 4, 2020.
2. FDA approves Saxenda® for the treatment of obesity in adolescents aged 12-17. [press release]. Plainsboro, NJ: Novo Nordisk; December 4, 2020.
3. Saxenda® [package insert]. Plainsboro, NJ: Novo Nordisk; 2020.