FDA Greenlights Victoza for Pediatric Diabetes

June 24, 2019

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.

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