Victoza Receives Expanded Indication to Treat Diabetes in Children
June 17, 2019 – The U.S. FDA has approved an expanded indication for Victoza® (liraglutide), manufactured by Novo Nordisk. The product, which was originally approved in 2010 to treat adults, is now approved for use as an adjunct to diet and exercise to improve glycemic control in patients 10 years and older who have type 2 diabetes mellitus.
Type 2 diabetes was once extremely rare in children, but the number of diagnosed cases has been on the rise the United States. An estimated 5,000 individuals under the age of 20 are diagnosed with type 2 diabetes each year, according to the U.S. Centers for Disease Control and Prevention (CDC). This form of diabetes occurs when the body is unable to use insulin properly and may not produce enough insulin, which leads to high blood sugar levels that can be dangerous.
In clinical trials, approximately 64% of pediatric patients who received Victoza achieved an A1c level (a measure of glycemic control) below 7%, compared to 37% of patients who received a placebo. The safety profile for pediatric patients was similar to that seen in adults. However, pediatric patients 10 years and older had a higher risk of hypoglycemia (low blood sugar) while taking Victoza whether or not they took other therapies for diabetes. Adult patients only see this risk increase when taking Victoza with insulin or other drugs that increase the amount of insulin the body makes.
Victoza’s recommended dosing for pediatric patients is 0.6mg administered via subcutaneous (SC) injection once daily. If needed for additional glycemic control, the dose can be increased to 1.2mg a day after one week. Patients who still need additional glycemic control after one week on the 1.2mg dose can be moved to a 1.8mg dose per day.
A black box warning cautions that there is a risk of thyroid C-cell tumors with Victoza. The drug should not be used by patients who have a personal or family history of medullary thyroid cancer (MTC) or by patients who have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
In addition to improving glycemic control in patients 10 years of age and older who have type 2 diabetes mellitus, Victoza is indicated to reduce the risk of major adverse cardiovascular events in adults who have type 2 diabetes mellitus and established cardiovascular disease.