FDA Approves Once-Weekly Insulin Icodec for Children With Type 2 Diabetes
The FDA announced Oct. 23 that insulin icodec (Awiqli) is now approved for patients 10 and older with type 2 diabetes, the first weekly insulin for children. The pediatric evidence is an 18-patient pharmacokinetic study, and type 1 diabetes remains off the label.
The Food and Drug Administration has approved once-weekly insulin icodec (Awiqli, Novo Nordisk) for children 10 years and older with type 2 diabetes, making it the first once-weekly insulin for pediatric patients with the disease, the agency announced Oct. 23.
The indication mirrors the adult label: an adjunct to diet and exercise to improve glycemic control. The FDA granted the application priority review.
What was the evidence?
The pediatric approval rests on pharmacokinetics, not a pediatric efficacy trial. The FDA cited a single-dose study (NCT05790681) in 18 patients aged 10 and older with type 2 diabetes. Children absorbed the first dose faster than adults, but modeling showed blood levels became similar to adult levels after the first few doses, and the agency said it expects similar glucose-lowering effects in children and adults.
Efficacy is extrapolated from the adult program. The FDA approved insulin icodec 700 units/mL for adults with type 2 diabetes in March, Healio reported, based on the four randomized, treat-to-target ONWARDS phase 3a trials. In ONWARDS 1, hemoglobin A1c fell 0.19 percentage points more at one year than with once-daily insulin glargine U-100, according to that report.
Eighteen children and a pharmacokinetic model are the pediatric evidence. The efficacy and hypoglycemia data clinicians will lean on come from adults.
Safety and the label
Hypoglycemia is the most common adverse reaction, and the FDA notes that severe episodes can cause seizures, loss of consciousness or death. Other common reactions include hypersensitivity, injection site reactions, lipodystrophy, pruritus, rash, edema and weight gain. Warnings cover medication errors and accidental overdose, hyperglycemia, hypokalemia, and fluid retention and heart failure with thiazolidinediones. The agency tells patients to check the label and the dose shown on the FlexTouch pen before each injection.
Type 1 diabetes remains outside the label. An FDA advisory committee voted against approval in May 2024, citing higher rates of level 2 and level 3 hypoglycemia in adults with type 1 diabetes in ONWARDS 6, and the agency issued a complete response letter in July 2024, Healio reported.
What it means in clinic
For pediatric endocrinologists, a weekly basal insulin may help adolescents who miss daily doses. Diana Isaacs, Pharm.D., an endocrine clinical pharmacy specialist at Cleveland Clinic, told Healio after the adult approval that "a big one is the frequency of injections" among the barriers to insulin use. She also noted that the adult starting dose of 70 units is higher than clinicians are used to, that titration is in 10-unit steps, and that the long half-life limits how fast a dose can be changed during acute illness or fasting.
That last point matters most in adolescents, whose intake and activity swing more than adults'. The FDA announcement did not give a pediatric starting dose, so before prescribing, confirm pediatric dosing in the updated prescribing information, check formulary coverage, and build a plan for sick days and missed meals with the family. For another recent look at glucose management in type 2 diabetes, see the CONNECT trial of continuous glucose monitoring.
Reported, fact-checked and edited by The Script Pad's editorial staff. See How we use AI.
This article is for professional education and does not replace clinical judgment. Treatment decisions should be based on the individual patient and current guidelines.
