Tresiba Approved for Pediatric Patients With Diabetes
The FDA has approved an expanded indication for Tresiba to include children and adolescents with diabetes.
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.