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November 25, 2020 09:00pm
By Sara Karlovitch, Assistant Editor
Liraglutide is the first noninsulin drug approved to treat T2D in pediatric patients since metformin was approved for pediatric use in 2000, according to the FDA.
Officials with the FDA today approved liraglutide (Victoza, Novo Nordisk) injection for treatment of pediatric patients age 10 years or older with type 2 diabetes (T2D).
Liraglutide is the first noninsulin drug approved to treat T2D in pediatric patients since metformin was approved for pediatric use in 2000, according to the FDA. Liraglutide has been approved to treat adult patients with T2D since 2010.
“The FDA encourages drugs to be made available to the widest number of patients possible when there is evidence of safety and efficacy,” said Lisa Yanoff, MD acting director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research, in a prepared statement. “Victoza has now been shown to improve blood sugar control in pediatric patients with type 2 diabetes. The expanded indication provides an additional treatment option at a time when an increasing number of children are being diagnosed with this disease.”
Although T2D primarily occurs in patients over the age of 45 years, the prevalence rate among younger patients has been rising dramatically over the past couple of decades. TheDiabetes Report Cardpublished by the CDC estimates that more than 5000 new cases of T2D are diagnosed each year among people younger than age 20 years in the United States.
Liraglutide improves blood sugar levels by creating the same effects in the body as the glucagon-like peptide (GLP-1) receptor protein in the pancreas. GLP-1 is often found in insufficient levels in T2D patients. Like GLP-1, liraglutide slows digestion, prevents the liver from making too much glucose, and helps the pancreas produce more insulin when needed.
Liraglutide also is indicated to reduce the risk of major adverse cardiovascular events in adults with T2D and established cardiovascular disease; however, its effect on major adverse cardiovascular events in pediatrics was not studied and it is not indicated for this use in children.
The efficacy and safety of liraglutide for reducing blood sugar in patients with T2D was studied in several placebo-controlled trials in adults and 1 placebo-controlled trial with 134 pediatric patients ages 10 years and older for more than 26 weeks. Approximately 64% of patients in the pediatric study had a reduction in their hemoglobin A1c (HbA1c) below 7% while on liraglutide, compared to 37% who achieved these results with the placebo.
The prescribing information for Novo Nordisk’s liraglutide injection includes a Boxed Warning to advise health care professionals and patients about the increased risk of thyroid C-cell tumors. For this reason, patients who have had, or have family members who have ever had medullary thyroid carcinoma (MTC) should not use liraglutide, nor should patients who have multiple endocrine neoplasia syndrome type 2 (MEN 2).
Liraglutide also carries warnings about pancreatitis, pen sharing, hypoglycemia when used in conjunction with certain other drugs known to cause hypoglycemia including insulin and sulfonylurea, renal impairment or kidney failure, hypersensitivity and acute gallbladder disease. The most common adverse effects are nausea, diarrhea, vomiting, decreased appetite, indigestion and constipation, according to the FDA.
FDA approves new treatment for pediatric patients with type 2 diabetes [news release]. Silver Spring, MD; June 17, 2019: FDA website. https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-pediatric-patients-type-2-diabetes. Accessed June 17, 2019.