乌鸦传媒

The GLP-1 receptor agonist liraglutide (Victoza) is now indicated for use in kids ages 10 and older with type 2 diabetes, the .

Following priority review, Novo Nordisk's once-daily injectable treatment becomes the first non-insulin treatment for pediatric type 2 diabetes since metformin was approved in 2000. The treatment is not indicated for individuals with type 1 diabetes.

Liraglutide was first approved for adult use in 2010, as an adjunct to diet and exercise in type 2 diabetes.

Approval relied primarily on the phase III , results of which were published in the in April, which found an average HbA1c decline of 0.64 percentage points after 26 weeks compared with placebo. Those on liraglutide received up to 1.8 mg/day as an adjunct to metformin with or without basal insulin. These benefits were also maintained up to 52 weeks of follow-up while off treatment. However, as expected with GLP-1 receptor agonists, rates of gastrointestinal adverse events were higher than with placebo.

"Victoza has now been shown to improve blood sugar control in pediatric patients with type 2 diabetes," commented Lisa Yanoff, MD, acting director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research, in the FDA's statement. "The expanded indication provides an additional treatment option at a time when an increasing number of children are being diagnosed with this disease."

At least two other GLP-1 agonists currently approved for adults with type 2 diabetes are also under study for pediatric patients, including (Trulicity) and (Bydureon, Byetta), as are some drugs in the DPP-4 inhibitor (e.g., ) and classes.

Victoza carries a boxed warning for the increased risk of thyroid C-cell tumors; the drug is contraindicated for patients with family histories indicating increased risk for such malignancies.

Comment