The FDA has approved a 3mg injection of liraglutide as a treatment for patients between the ages of 12 and 17 who weigh more than 132 pounds or have a body mass index comparable to adults with a BMI of 30 kg/m2 or more.
According to a press release from the manufacturer, the approval is for the combination of the drug with a reduced-calorie diet and increased physical activity.
The release noted the prevalence of overweight children and adolescents has doubled from 1 in 10 to 1 in 5 over the past 20 years, with researchers showing a connection to children being overweight when both parents are as well.
“New options to treat adolescents who live with obesity can bring much-needed hope to families and help address this growing epidemic,” said Aaron Kelly, PhD, of the University of Minnesota, in the release. “With up to 90% of adolescents with obesity likely to have it as adults and thus at increased risk for developing weight-related complications, it’s important to address weight care and offer support early on.”
Liraglutide was studied in a phase 3a trial earlier this year, with results published in the New England Journal of Medicine. The release noted that during the 56-week study, patients saw several positive results when treated with the drug, including reductions in BMI and mean body weight, when compared to placebo.
The release noted adverse events in adolescent patients were similar to adults taking the medication. The most common adverse reactions included nausea, vomiting, and diarrhea.