Novo Nordisk submitted the supplemental New Drug Application (sNDA) based on the results of the BEGIN Young 1 trial, a multi-national, 26-week, phase 3b, randomized, controlled, clinical trial.
Officials with the FDA have approved an expanded indication for insulin degludec injection 100 U/mL, 200 U/mL, (Tresiba, Novo Nordisk), a once-daily, long-acting basal insulin, to be used in children as young as age 1 with type 1 and type 2 diabetes, according to a press release from Novo.1
Novo Nordisk submitted the supplemental New Drug Application (sNDA) based on the results of the BEGIN Young 1 trial, a multinational, 26-week, phase 3b, randomized, controlled, clinical trial in which children were administered either Tresiba once-daily or Levemir (insulin detemir [rDNA origin] injection) administered once-daily or twice daily, both in combination with insulin aspart.
The results showed that Tresiba in combination with insulin aspart effectively improved glycemic control. The most common adverse events were infection, hypoglycemia, and hyperglycemia.2
Insulin degludec injection 100 U/mL, 200 U/mL is available in Novo Nordisk's latest insulin delivery device — FlexTouch – as a 100 units/mL or 200 units/mL pen. Tresiba® U-100 FlexTouch can deliver up to 80 units of insulin in a single injection. Tresiba U-200 FlexTouch can dose up to 160 units in a single injection.
"We are seeing a rise in the number of children and adolescents with diabetes in the U.S., especially those with type 2, and are proud to support these patients by offering new and effective treatment options," Todd Hobbs, MD, US chief medical officer, Novo Nordisk, said in the press release.
1. Novo Nordisk receives FDA Approval of Tresiba® (insulin degludec injection 100 U/mL, 200 U/mL) for use in children and adolescents with diabetes [news release]. Plainsboro, NJ. Novo Nordisk. December 19, 2016. https://goo.gl/Vemm4V.
2. Thalange N, Deeb L, Lotova V, et al. Insulin degludec in combination with bolus insulin aspart is safe and effective in children and adolescents with type 1 diabetes. Pediatric Diabetes. 2015; 164-176.