Novo Nordisk announced that the Food and Drug Administration (FDA) has approved an expanded use for Tresiba (insulin degludec) injection to improve glycemic control in children and adolescents with both type 1 and type 2 diabetes.
Tresiba, a long-actin insulin, was initially approved in September 2015 to improve glycemic control in adults with type 1 or type 2 diabetes mellitus. This expanded approval makes Tresiba the only basal insulin for use in diabetes patients as young as age 1.
The supplemental New Drug Application (sNDA) for Tresiba included study data from the Phase 3b BEGIN Young 1 trial, a 26-week, multinational, randomized, controlled, open-label, parallel-group, treat-to-target non-inferiority trial with a 26-week extension. The study compared the safety and efficacy of once-daily Tresiba vs. once- or twice-daily Levemir (insulin detemir [rDNA origin]) injection, both in combination with insulin aspart in patients aged 1–17 years with type 1 diabetes. Tresiba in combination with insulin aspart was found to effectively improve glycemic control.
The use of Tresiba in patients aged ≥1 year with type 2 diabetes mellitus is also supported by data from adequate and well-controlled studies in adults with type 2 diabetes.
Tresiba is available as 100 Units/mL and 200 Units/mL strengths in the FlexTouch pens. Tresiba U-100 FlexTouch can deliver up to 80 units per single injection and the U-200 FlexTouch can deliver up to 160 units per single injection.