FDA Approves Liraglutide (Victoza) for Treatment of Pediatric Type 2 Diabetes in Patients Aged 10 and Older

Today, the U.S. FDA announced the approval of an expanded indication for Novo Nordisk’s Victoza (liraglutide) for the treatment of type 2 diabetes in patients aged 10 years and older. Notably, this is the first new non-insulin medication for type 2 diabetes approved for pediatric patients since metformin was authorized for the treatment of children with type 2 diabetes in 2000.

Type 2 diabetes is the most common form of diabetes. Although it typically occurs in adults, the prevalence of type 2 diabetes has risen significantly among younger populations over the past two decades. According to estimates by the U.S. Centers for Disease Control and Prevention (CDC), there are more than 5,000 new cases of type 2 diabetes annually among individuals under the age of 20 in the United States.

Liraglutide is a glucagon-like peptide-1 (GLP-1) analog developed by Novo Nordisk. It exerts effects similar to those of GLP-1, delaying gastric emptying, inhibiting excessive hepatic glucose production, and stimulating insulin secretion from the pancreas. The drug was approved in 2010 for the treatment of adults with type 2 diabetes.

▲Liraglutide (Image source: Victozapro.com)

This approval was primarily based on the results of clinical trials of liraglutide in adult patients and a placebo-controlled clinical trial in pediatric patients aged 10 years and older. In this trial, 134 pediatric patients received treatment with either liraglutide or placebo. Among patients in the liraglutide group, 64% achieved a reduction in glycated hemoglobin (HbA1c) levels to below 7%, compared to 37% in the placebo group. HbA1c is a common test used to assess diabetes control in patients. Concomitant insulin therapy did not affect the trial outcomes.

“The FDA encourages making new drugs available to as many patients as possible while ensuring safety and efficacy,” said Dr. Lisa Yanoff, Acting Director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “Liraglutide can improve glycemic control in pediatric patients with type 2 diabetes. With the rising prevalence of type 2 diabetes in children, this indication expansion provides more treatment options for these pediatric patients.”

References:

[1] FDA approves new treatment for pediatric patients with type 2 diabetes. Retrieved June 17, 2019, from https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-pediatric-patients-type-2-diabetes

Flash | FDA Approves Expanded Indication for Liraglutide, the First New Drug for Pediatric Type 2 Diabetes in Nearly 20 Years

▽Follow [WuXi AppTecDe】WeChat Official Account