FDA approves Novo Nordisk's Victoza for type 2 diabetes in paediatric patients

Novo Nordisk on Monday announced that the FDA expanded approval for Victoza (liraglutide) injection for use in children and adolescents with type 2 diabetes aged 10 years or older, marking the first approval of a glucagon-like peptide-1 (GLP-1) receptor agonist for this condition in this patient population. The company noted that "Victoza provides this population with a new treatment option beyond metformin and insulin for the first time in 19 years".

The approval was based on the ELLIPSE trial involving 134 patients aged 10 years to 17 years. In the study, the results of which were unveiled in April, the therapy, when added to metformin with or without basal insulin, was shown to significantly reduce HbA1c at 26 weeks and 52 weeks versus placebo, with the percentage of children and adolescents achieving HbA1C levels of less than 7% at week 26 being significantly higher in those treated with Victoza compared to those treated with placebo (63.7% versus 36.5% respectively).

Lisa Yanoff, acting director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research, remarked "the expanded indication provides an additional treatment option at a time when an increasing number of children are being diagnosed with this disease."   

Victoza filing was previously granted priority review for this indication, while the therapy has been authorised in the US as an adjunct to diet and exercise for improving blood glucose control in adults with type 2 diabetes since 2010. Sales of the GLP-1 receptor agonist fell 4 percent in the first quarter compared to the same period last year to DKK 5.7 billion ($856 million).  

For additional analysis on the diabetes market, see KOL Views: Reassessing who will control GLP-1 market – near- and long-term – in wake of ADA. See also ViewPoints: Questions plague Eli Lilly, Novo Nordisk's duelling GLP-1 strategies.

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