FDA approves Victoza for children with type 2 diabetes
The FDA announced today the approval of liraglutide for treating children aged at least 10 years with type 2 diabetes.
“The FDA encourages drugs to be made available to the widest number of patients possible when there is evidence of safety and efficacy,” Lisa Yanoff, MD, acting director of the division of metabolism and endocrinology products in the FDA’s Center for Drug Evaluation and Research, said in an FDA press release. “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.”
According to the release, since metformin was introduced in 2000, there have been no other non-insulin medications approved for children with type 2 diabetes until liraglutide (Victoza, Novo Nordisk), which became available for the adult type 2 diabetes population in 2010.
Working in the same way as a GLP-1, the drug inhibits excess glucose production in the liver and improves insulin production in the pancreas. Digestion can also be slowed for those who use the treatment, according to the release.
The approval was made based on findings from a placebo-controlled trial in which 64% of children using liraglutide and 37% taking a placebo achieved an HbA1c level of less than 7%, the release stated.
The FDA noted that there has not been sufficient research pertaining to liraglutide’s potential to prevent major cardiovascular events in the pediatric population and that it should not be used by those with type 1 diabetes, diabetic ketoacidosis, medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.