The FDA approved Novo Nordisk’s Victoza for pediatric diabetics, the first treatment of its kind in two decades.
Victoza (liraglutide) is already a blockbuster for the Danish drug giant: Sales approached nearly $3.7 billion last year. It’s now the first non-insulin treatment approved for Type 2 diabetes in pediatric patients since the FDA greenlighted metformin in 2000.
The approval, granted under the agency’s priority review program, came after several placebo-controlled trials in adults and one placebo-controlled trial enrolling 134 patients for 26 weeks or more. Sixty-four percent of children and adolescents in that trial saw their hemoglobin levels drop by seven percent or more, compared to 37 percent in the placebo group.