FDA NewsPerspective

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.

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.

    Perspective
    Yehuda Handelsman

    Yehuda Handelsman

    This expanded indication for a non-insulin injectable in the pediatric population is wonderful news. There are at least 45,000 children diagnosed with type 2 diabetes every year. The numbers may, in fact, even be higher, especially in minority populations. Type 2 diabetes comes with obesity. Until now, we only had two drugs approved for this population beyond lifestyle modification, which can be difficult for children. The only oral medication approved for children with type 2 diabetes is metformin. Initially, it was difficult to convince clinicians to treat children with this drug, but, eventually, they did. At the end of the day, clinicians will again need to be educated with respect to prescribing liraglutide for this population. This drug has been on the market for almost 10 years. We are very familiar with it, and it is safe. It requires one injection per day, improves both fasting blood glucose and postprandial glucose, works well with metformin, and also helps with weight loss, which is so important in this population. I hope Novo Nordisk will embark on a strong education effort, both to identify children with obesity and type 2 diabetes, and work with the clinicians who are managing them.

    • Yehuda Handelsman, MD, FACP, FNLA, MACE
    • Endocrine Today Editorial Board Member
      Medical Director and Principal Investigator
      The Metabolic Institute of America
      Tarzana, California

    Disclosures: Handelsman reports he has received research grants, consultant and speakers’ fees or honoraria from Aegerion, Amarin, Amgen, AstraZeneca, Boehringer Ingelheim, BI-Lilly, Bristol-Myers Squibb, Eisai, Gan & Lee, Grifols, Hanmi, Intarcia, Janssen, Lexicon, Lilly, Merck, Novo Nordisk, Regeneron and Sanofi.