FDA Extends Once-Weekly Insulin to Youth With Type 2 Diabetes

Once-weekly insulin icodec-abae (Awiqli; Novo Nordisk) is now approved to improve glycemic control in children 10 years and older with type 2 diabetes (T2D), making it the first weekly basal insulin available to this age group.¹

The FDA approved the 700 units/mL injection as an adjunct to diet and exercise, cutting basal insulin injections from 7 per week to 1. The decision comes 7 months after the agency cleared icodec for adults with T2D in March 2026, and the company said the therapy is available at more than 70,000 pharmacies nationwide.

"Individuals with type 2 diabetes and their families seek treatment options that may allow for more individualized care," said Michael Radin, MD, executive medical director at Novo Nordisk, in a statement. “It is important to continue to discover advanced treatments for the populations that need them today.”

Pediatric Label Leans on Adult Trials and a Single-Dose PK Study

The pediatric approval was supported by adequate and well-controlled studies in adults with T2D, including the pivotal ONWARDS program, plus a single-dose pharmacokinetic (PK) study in patients aged 10 to younger than 18 years. That study, published in Pediatric Diabetes, enrolled 18 insulin-treated participants at 7 US sites who received a single planned dose of 5.6 U/kg of icodec.² Participants had a mean age of 14.4 years, a mean BMI of 38.5 kg/m², and a mean hemoglobin A_1C (HbA_1c) of 7.5%.

Icodeic exposure observed after 1 dose and extrapolated to steady state suggested the drug covers the full 1-week dosing interval. The shape of the PK profile was essentially similar to that previously seen in adults, although overall exposure was slightly higher in the younger patients. The authors suggested lower insulin sensitivity during puberty and the cohort's higher BMI may explain the difference, and because icodec is titrated to individual needs, they considered the modestly greater exposure of limited clinical relevance.

Six adverse events occurred in 2 participants, all mild and resolved. There were no serious or severe adverse events, hypersensitivity or injection site reactions, or hyperglycemic episodes, and 1 level 1 hypoglycemic episode was reported. The authors noted that participants received only 1 fixed dose and that pharmacodynamics were not assessed.

Weekly Dosing Aims at Adherence Gaps in Youth-Onset T2D

Projections estimate between 30,000 and 84,000 US youths will have T2D by 2050, and adherence to diabetes medication has been shown to decline over time in this population, the study authors wrote. A once-weekly regimen would reduce basal insulin injections from at least 365 to 52 per year.

"Children with type 2 diabetes face an aggressive disease trajectory, and achieving sustained glycemic control in children with type 2 diabetes remains a major challenge," said Eda Cengiz, MD, MHS, professor of pediatrics at the University of California, San Francisco, in the announcement.¹ "For more than 20 years daily basal insulin injections have been a main form of treatment in pediatric diabetes care, but children living with type 2 diabetes may face challenges staying on a daily treatment routine."

The adult approval in March came after the FDA rejected icodec in July 2024, following a May 2024 FDA advisory committee vote against approval over higher rates of level 2 and level 3 hypoglycemia among adults with type 1 diabetes in the ONWARDS 6 (NCT04848480) trial; the adult label excludes type 1 diabetes.³ The pediatric indication is likewise limited to T2D, and safety and efficacy have not been established in children younger than 10 years. Common adverse effects include hypoglycemia, serious allergic reactions, injection site reactions, lipodystrophy, itching, rash, swelling of the hands and feet, and weight gain.¹

References

1. Novo's Awiqli receives FDA approval as the first and only once-weekly insulin for children 10 years of age and older with type 2 diabetes. News release. Novo Nordisk. October 23, 2026. Accessed October 23, 2026. https://www.novonordisk-us.com/media/news-archive/news-details.html?id=918803
2. Van Name M, Ásbjörnsdóttir B, Murphy Gomes M, et al. Pharmacokinetic properties of once-weekly insulin icodec in children and adolescents with type 2 diabetes. Pediatr Diabetes. 2025;2025:5514927. doi:10.1155/pedi/5514927
3. Monostra M. FDA approves once-weekly basal insulin for adults with type 2 diabetes. Healio. March 27, 2026. Accessed October 23, 2026. https://www.healio.com/news/endocrinology/20260518/fda-approves-onceweekly-basal-insulin-for-adults-with-type-2-diabetes