U of M Medical School research led to FDA approval of new anti-obesity medication for adolescents
MINNEAPOLIS, MN-December 9, 2020 – One in five teenagers in the U.S. is afflicted with obesity and the prevalence continues to rise. That statistic could now change after research spearheaded by a University of Minnesota Medical School professor led to the approval of the first anti-obesity medication for adolescents in the U.S. in over 17 years.
The U.S. Food and Drug Administration (FDA) approved an updated label for liraglutide (Saxenda®) injection 3.0 milligrams for use in the treatment of obesity in adolescents between the ages of 12 and 17 with a body weight above 60 kilograms (or 132 pounds) and an initial body mass index (BMI) corresponding to 30 kg/m2 or greater for adults. The treatment will be used as an adjunct to reduced-calorie meals and increased physical activity.
Aaron S. Kelly, PhD, professor in the Department of Pediatrics and co-director of the Center for Pediatric Obesity Medicine at the U of M Medical School, was the international principal investigator and served as the signatory author for the phase 3 clinical trial that led to FDA approval. The study was published earlier this year in the New England Journal of Medicine and presented at Endo 2020, the Endocrine Society’s annual meeting. It investigated the effect of liraglutide, compared to a placebo, on weight management in adolescents with obesity as an adjunct to lifestyle therapy. The study demonstrated liraglutide was effective in reducing BMI and body weight in adolescents with obesity. The Center for Pediatric Obesity Medicine, led by Claudia Fox, MD, MPH, as the site principal investigator, participated in the multicenter trial by enrolling patients from the M Health Fairview system. Kelly's work builds on partnered funding support from the U of M's Clinical and Translational Science Institute and Children's Minnesota, which awarded a pilot grant in 2010 to Kelly and Children's Minnesota research partner Jennifer Abuzzahab, MD.
Liraglutide was previously approved for the treatment of adult obesity in 2014. The efficacy in the adult phase 3 trial was similar to what Kelly and colleagues showed in the phase 3 adolescent trial.
“This represents an important milestone for the field of pediatric obesity medicine. It has been nearly two decades since the last anti-obesity medication was approved by the FDA for pediatric use,” Kelly said. “Pediatricians now have another safe and effective tool to help their patients lose weight and keep it off. More pharmacotherapy options are needed, but this is a great start.”
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