according to a news release from the agency. The approval comes after granting the application Priority Review, which means the FDA aimed to take action on it within 6 months instead of the usual 10 months seen with a Standard Review.
Liraglutide injection has been approved for treatment of adults with type 2 diabetes since 2010, but this is the first noninsulin treatment for pediatric patients since metformin received approval for this population in 2000.
“The expanded indication provides an additional treatment option at a time when an increasing number of children are being diagnosed with [type 2 diabetes],” said Lisa Yanoff, MD, acting director of the division of metabolism and endocrinology products in the agency’s Center for Drug Evaluation and Research.
The approval is based on efficacy and safety results from several placebo-controlled trials in adults, and one trial in 134 pediatric patients aged 10 years or older. In the latter trial, which ran for more than 26 weeks, hemoglobin A1c levels fell below 7% in approximately 64% of patients treated with liraglutide injection, compared with 37% of those who received placebo. Those results were seen regardless of whether patients concomitantly used insulin.
Although an increase in hypoglycemia risk has sometimes been seen in adult patients taking liraglutide injection with insulin or other drugs that raise insulin production, this heightened risk was seen in the pediatric patients regardless of whether they took other therapies for diabetes.
Liraglutide injection carries a Boxed Warning, the FDA’s strongest warning, for heightened risk of thyroid C-cell tumors. Therefore, the agency recommends against patients with history or family members with history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 using this treatment. Among its other warnings are those pertaining to patients with renal impairment or kidney failure, pancreatitis, and/or acute gallbladder disease.
The most common side effects are nausea, diarrhea, vomiting, decreased appetite, indigestion, and constipation. The full prescribing information can be found on the FDA website.