On Monday, the U.S. Food and Drug Administration (FDA) approved Victoza (liraglutide) injection for the treatment of type 2 diabetes in children 10 years and above.
Victoza is the first non-insulin drug that has got the FDA approval to treat type 2 diabetes in children since metformin was approved for use in children in 2000. The drug has been approved to treat type 2 diabetes in adult since 2010.
Dr. Lisa Yanoff, acting director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research, said, “The FDA encourages drugs to be made available to the widest number of patients possible when there is evidence of safety and efficacy.”
She added, “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.”
Please note that Victoza is not an insulin substitute and is not recommended for patients with type 1 diabetes. It is also not indicated to patients with diabetic ketoacidosis, a diabetic complication “where the body breaks down fat too quickly because there is inadequate insulin or none at all.”
The safety and efficacy of Victoza for controlling blood sugar levels in patients with type 2 diabetes was studied in several clinical trials in adults and one clinical trial with 134 pediatric patients above 10 years for more than 26 weeks.
The pediatric study found that nearly 64% of children had good control in their hemoglobin A1c (HbA1c) while on Victoza.
Meanwhile, the FDA warned, “Pediatric patients 10 years and older taking Victoza had a higher risk of hypoglycemia regardless of whether they took other therapies for diabetes.”
Victoza includes a Boxed Warning that advises medical professionals and patients about the increased risk of thyroid C-cell tumors. Therefore, patients who have or have had a family history of medullary thyroid carcinoma should not use Victoza. Also, it should not be used by patients with an endocrine system condition called type 2 multiple endocrine neoplasia syndrome. The FDA approval of Victoza was granted to Novo Nordisk, a Danish multinational pharmaceutical company.