Novo Nordisk Wins Expanded Approval for Victoza

joreks / Shutterstock

 

Novo Nordisk’s diabetes drug Victoza (liraglutide) earned approval from the U.S. Food and Drug Administration (FDA) for an expanded indication for use in children ages 10 to 17 years who have type 2 diabetes.

The approval marks the first glucagon-like peptide-1 (GLP-1) receptor agonist approved for children and adolescents with type 2 diabetes, Novo announced late Monday. With the approval of the new indication, Novo Nordisk said Victoza now provides a new treatment option for this age group “beyond metformin and insulin for the first time in 19 years.” Victoza was first approved in the U.S. in 2010 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

The expanded indication is based on the Phase III ELLIPSE trial, which was the first late-stage trial completed in children and adolescents with type 2 diabetes in more than 10 years. In the ELLIPSE study, the youthful patients were randomized to receive Victoza or placebo in combination with or without basal insulin for a more than 26-week double-blinded period followed by a 26-week open-label extension period. Full results of the ELLIPSE trial were presented in May at the Pediatric Endocrine Society (PES)/Pediatric Academic Societies (PAS) Annual Meeting in Maryland. They were also published in the New England Journal of Medicine. As BioSpace reported at the time, Victoza when added to metformin, with or without concurrent insulin treatment, significantly reduced A1C levels at 26 weeks to a level of 0.64% in comparison to placebo, which reduced AIC to 0.42%. That was the primary endpoint of the Phase III study. The drug also maintained that AIC reduction through 52 weeks to 0.5% at 52 weeks, which was the secondary endpoint.

The safety profile in the pediatric group was similar to that as seen in adults. The most common adverse events were gastrointestinal events. Other issues included headache, nasopharyngitis (common cold), dizziness, gastroenteritis, upper respiratory tract infection, rash, pyrexia (fever) and decreased appetite.

Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk said the company is delighted Victoza’s label expansion. Gaining approval in the pediatric indication in type 2 diabetes is a landmark for the company, he said, restating that it is the first-ever GLP-1 receptor agonist approved for this population.

“The prevalence of type 2 diabetes in the U.S. is ever increasing and we are seeing a higher number of diagnoses in children and adolescents, for whom there are limited treatment choices. Victoza will provide a new option for clinicians treating this challenging disease, helping to address the growing need for this population,” Thomsen said in a statement.

Citing statistics from the World Health Organization, Novo Nordisk said type 2 diabetes is becoming increasingly more common in children and young adults. However, due to insufficient data regarding newly occurring cases globally, Novo noted that it is difficult to assess just how many new patients there are on a global scale. In the United States though, it is estimated that type 2 diabetes accounts for approximately half of all new cases of diabetes in adolescents and a third of these cases are undiagnosed, Novo Nordisk said in its announcement.