Non-Insulin Drug Approved for Kids with Type 2 Diabetes by FDA
On June 17th, 2019, Victoza, a liraglutide (GLP-1) injection by Novo Nordisk, was approved by the U.S. Food and Drug Administration on Monday for treatment in children as young as 10 years old and older with type 2 diabetes (T2D). Prior to this approval, Victoza was only FDA-approved to treat adults with type 2 diabetes. This is the first non-insulin drug approved in almost 20 years to be used specifically for young people with T2D. Metformin was approved for pediatric use in 2000.
Approval of this drug in pediatric patients was based on data from the ELLIPSE Study (Efficacy and Safety Liraglutide in Combination with Metformin Compared to Metformin Alone in Children and Adolescents with Type 2 diabetes).
“Victoza has now been shown to improve blood sugar control in pediatric patients with type 2 diabetes,” said Lisa Yanoff, acting director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “The expanded indication provides an additional treatment option at a time when an increasing number of children are being diagnosed with this disease.”
Liraglutide helps in the management of blood glucose levels by preventing the production of hepatic glucose and helping the pancreas to produce more insulin and slowing digestion. It also keeps the liver from making too much glucose. Warnings for the use of liraglutide include pancreatitis and hypoglycemia when used with other glucose-lowering drugs such as insulin.
Per the CDC’s Diabetes Report Card in 2017, about 5,300 young people between the ages of 10 and 19 were newly diagnosed with type 2 diabetes between the years 2011-2012. Recent presentations at the American Diabetes Association’s conference in San Francisco revealed other results about the progression of type 2 diabetes in youth, notably from the TODAY2 and RISE clinical trials.