Healthcare company Novo Nordisk reported on Monday the receipt of approval from the US Food and Drug Administration (FDA) for an expanded indication for Victoza (liraglutide) injection to lower blood sugar along with diet and exercise in children and adolescents aged 10-17 years with type 2 diabetes.
Victoza, which the first glucagon-like peptide-1 (GLP-1) receptor agonist approved for children and adolescents with type 2 diabetes, provides this population with a new treatment option beyond metformin and insulin for the first time in 19 years, added the company
This US FDA update is based on results from the company's global ELLIPSE trial, a phase 3, randomised, placebo-controlled, parallel group, multinational trial in which 135 children and adolescents 10-17 years of age were randomised 1:1 to treatment with Victoza (liraglutide) injection up to 1.8 mg/day or placebo, in combination with metformin, with or without basal insulin, and diet and exercise for a 26-week, double-blind period, followed by a 26-week open label extension (total 52 weeks).
According to the company, Victoza (liraglutide) injection 1.2 mg or 1.8 mg is an injectable prescription medicine used along with diet and exercise to lower blood sugar (glucose) in adults and children who are ten years of age and older with type 2 diabetes mellituso reduce the risk of major cardiovascular events.
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