Victoza OK’d for Kids 10 and Up With T2D
The GLP-1 receptor agonist liraglutide (Victoza) is currently indicated for use in kids ages ten and older with type 2 diabetes, the FDA announced.
Following priority review, Novo Nordisk’s once-daily injectable treatment becomes the very first non-insulin treatment for pediatric type 2 diabetes since metformin was approved in 2000. The procedure is not indicated for people with type 1 diabetes.
Liraglutide was initially approved for adult use in 2010, is an adjunct to diet and exercise in type 2 diabetes.
Approval relied primarily on the phase III Ellipse trial, results of that have been published in the New England Journal of Medicine in April, which found the average HbA1c decline of 0.64 percentage points after 26 weeks compared with placebo. Those on liraglutide received up to 1.8 mg/day is an adjunct to metformin with or without basal insulin. These benefits were also maintained up to 52 weeks of follow-up while off treatment. However, not surprisingly, with GLP-1 receptor agonists, rates of gastrointestinal adverse events were more than with placebo.
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“Victoza has now been shown to enhance blood glucose control in pediatric patients with type 2 diabetes,” commented Lisa Yanoff, MD, acting director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research, in the FDA’s statement. “The expanded indication provides an additional treatment option at a time when an increasing amount of children are being diagnosed with this disease.”
At the very least, two other GLP-1 agonists currently approved for adults with type 2 diabetes are also under study for pediatric patients, including dulaglutide (Trulicity) and exenatide (Bydureon, Byetta), as are some drugs in the DPP-4 inhibitor (e.g., sitagliptin) and SGLT-2 inhibitor classes.
Victoza possesses boxed warning for the increased risk of thyroid C-cell tumors; the drug is contraindicated for patients with family histories, indicating increased risk for such malignancies.