FDA Approves New Option for Pediatric Type 2 Diabetes

The FDA has approved Victoza (liraglutide) injection for the treatment of pediatric patients 10 years or older with type 2 diabetes.

This is the first non-insulin drug approved for this purpose since metformin in 2000. Victoza was first approved to treat type 2 diabetes in adult patients in 2010.

Notably, Victoza is not a substitute for insulin and is not indicated for patients with type 1 diabetes or diabetic ketoacidosis.

Its safety and efficacy were examined in a several placebo-controlled trials in adults and 1 trial including 134 pediatric patients. Of these pediatric patients, approximately 64% saw a reduction in hemoglobin A1c to below 7% while taking Victoza, compared with 37% of those who were given placebo.

The drug includes a Boxed Warning regarding an increased risk of thyroid C-cell tumors. It also carries warnings about pancreatitis, hypoglycemia when used in conjunction with certain drugs known to cause hypoglycemia (including insulin and sulfonylurea), renal impairment or kidney failure, hypersensitivity and acute gallbladder disease. The most common side effects associated with Victoza are nausea, diarrhea, vomiting, decreased appetite, indigestion and constipation.

—Michael Potts

Reference:

FDA approves new treatment for pediatric patients with type 2 diabetes [press release]. June 17, 2019. https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-pediatric-patients-type-2-diabetes?utm_campaign=061719_PR_FDA%20approves%20new%20treatment%20for%20pediatric%20patients%20with%20type%202%20diabetes&utm_medium=email&utm_source=Eloqua.