[12/4/2020] The U.S. Food and Drug Administration has approved a supplemental indication for Saxenda (liraglutide) for chronic weight management among pediatric patients aged 12 and older who are obese, as defined by specific body mass index (BMI) cut-offs for age and sex that correspond to a BMI 30 kg/m2 or higher for adults, and who weigh more than 60 kg (132 pounds). The U.S. Food and Drug Administration has approved Saxenda (liraglutide) for chronic weight management among patients aged 12 and older who are obese, as defined by specific body mass index (BMI) cut-offs for age and sex that correspond to a BMI 30 kg/m2 or higher for adults, and who weigh more than 60 kg (132 pounds). Saxenda is an adjunct (additional therapy) to a reduced-calorie diet and greater physical activity.
Saxenda has been approved since December 2014 for chronic weight management in adults with a BMI of 30 kg/m2 or higher or a BMI of 27 kg/m2 or higher who have at least one weight-related condition. It is an adjunct to a reduced calorie diet and greater physical activity for adults as well.
Obesity is a health concern among adolescents, with 20 percent of individuals aged 12-19 years considered obese, according to the Centers for Disease Control and Prevention. Obesity may increase the risk of many diseases, such as diabetes, heart disease and certain cancers. Obesity in childhood can also lead to self-esteem problems and depression. Many obese children are likely to become obese adults.
Saxenda was evaluated in a 56-week, double-blind, placebo-controlled study among 251 patients aged 12 to 17 with a BMI that corresponded to 30 kg/m2 or greater for adults and at the 95th percentile or greater for their age and sex. After a 12-week period of counseling about a reduced-calorie diet and increased physical activity, patients were randomly assigned to receive Saxenda once a day or a placebo once a day.
The primary endpoint was the change in BMI standard deviation score (BMI SDS), a standard measurement of how much the BMI of a growing person compares to the average BMI for his or her age and sex; BMI SDS can be useful in pediatric obesity studies because a growing person’s BMI SDS tends to stay the same over time whereas a person’s weight increases during childhood. After 56 weeks, patients treated with Saxenda had an average 0.23 reduction in their BMI SDS from the beginning of the study whereas patients taking the placebo had, on average, no reduction in their BMI SDS. In addition, patients taking Saxenda lost, on average, 2.65% of their body weight while patients receiving the placebo gained an average 2.37% of their body weight. (Change in body weight was a secondary endpoint that was not evaluated for statistical significance but was consistent with the primary endpoint of BMI SDS.)
Saxenda contains liraglutide and should not be administered with other liraglutide-containing products, nor with any other GLP-1 receptor agonist. Use of Saxenda for pediatric patients with type 2 diabetes has not been established. The drug has also not been proven to treat weight loss in combination with other products (such as prescription drugs, over-the-counter drugs, and herbal preparations).
There is a boxed warning on the Saxenda prescribing information about the risk of thyroid c-cell tumors. The most common adverse reactions reported in the pediatric clinical trial included gastrointestinal side effects (such as nausea, vomiting, and diarrhea), dizziness and fever. There was one suicide in the trial in the Saxenda treatment group, so patients should be monitored for depression and suicidal thoughts. Additionally, hypoglycemia (low blood sugar) occurred in 15% of patients receiving Saxenda compared to 4% of patients receiving placebo. Treatment should be discontinued if pancreatitis (pancreas inflammation) is suspected. Patients should also be monitored for acute gallbladder disease, heart rate increase, kidney impairment, and hypersensitivity (allergic) reactions.
FDA granted this supplement approval of Saxenda to Novo Nordisk Inc.