First non-insulin drug for pediatric use approved in nearly 20 years.
The FDA has approved Victoza (liraglutide, Novo Nordisk), to treat type-2 diabetes in pediatric patients 10 years and older. Though Victoza was approved for use in adults in 2010, this is the first noninsulin drug to be approved for the use in pediatric patients since 2000. The approval comes nearly two months after the completion of the first-ever Phase 3 clinical trial that included children and adolescents with type-2 diabetes in over a decade.
Liraglutide, indicated as an adjunct to diet and exercise to improve glycemic control, creates the same effects in the body as the glucagon-like peptide (GLP-1) receptor protein in the pancreas. The drug slows digestion, prevents the liver from producing excess glucose, and helps the pancreases produce more insulin when needed. Liraglutide is not intended as a substitute for insulin, according to the safety label.
Liraglutide is injected subcutaneously into the abdomen, thigh, or upper arm, once daily independent of meals. The initial dosage is 0.6 mg per day for one week, increased to 1.2 mg injections thereafter. The maximum dosage is 1.8 mg to achieving additional glycemic control. Patients in the ELLIPSE study received that dosage.
Victoza is contraindicated in patients with personal or family history of medullary thyroid carcinoma, patients with multiple endocrine neoplasia syndrome type 2, or those who have experienced a prior serious hypersensitivity reaction to Victoza or any of its product components.
Adverse reactions reported with Victoza in adults include nausea, diarrhea, vomiting, decreased appetite, dyspepsia, and constipation. In the ELLIPSE trial, adverse reactions that occurred in more than 5% of the child or adolescent trial participants included headache, nasopharyngitis, dizziness, gastroenteritis, upper respiratory tract infection, rash, pyrexia, and decreased appetite.