The US Food and Drug Administration (FDA) has approved an expanded indication for Tresiba® (insulin degludec injection 100 U/mL, 200 U/mL) for use in children and adolescents with diabetes, Novo Nordisk announced in a press release.
Tresiba, a once-daily, long-acting basal insulin, is now indicated to improve glycemic control in patients aged 1 year and older with type 1 or type 2 diabetes.
The supplemental new drug application (NDA) was submitted based on results of the BEGIN™ Young 1 trial (ClinicalTrials.gov identifier: NCT01513473), a multinational, 26-week, phase 3b, randomized, controlled, open-label, parallel-group, treat-to-target noninferiority trial comparing the efficacy and safety of once-daily Tresiba with once- or twice-daily Levemir® (insulin detemir [rDNA origin] injection, Novo Nordisk); both treatments were administered in conjunction with insulin aspart.
Study results indicated that Tresiba plus insulin aspart effectively improved glycemic control; the most commonly reported adverse events were infection, hypoglycemia, and hyperglycemia.
Tresiba is available for use with Novo Nordisk’s FlexTouch® insulin delivery device in a 100 U/mL or 200 U/mL pen.
- 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. Published December 19, 2016. Accessed December 19, 2016.