FDA Approves First Once-Weekly Insulin for Children With Type 2 Diabetes

The US Food and Drug Administration has approved the first once-weekly basal insulin for children with type 2 diabetes, a move that could cut long-acting insulin injections from seven a week to one for some young patients. The agency approved Novo Nordisk’s Awiqli (insulin icodec-abae) injection, 700 units/mL, on 23 October 2026 for children aged 10 and older, alongside diet and exercise, to improve blood sugar control.

The decision extends an approval for adults with type 2 diabetes granted in March 2026, according to Contemporary Pediatrics.

What Is Awiqli and How Does It Work?

Awiqli is a long-acting, or “basal”, insulin. Like other basal insulins, it helps glucose move from the blood into cells and reduces the amount of glucose produced by the liver, but it is designed to work over a weekly dosing interval rather than a day, the FDA said. It is given on the same day each week using a FlexTouch pen, and a missed dose may be taken within four days, according to the prescribing information summarised by Contemporary Pediatrics.

What Evidence Supported the Approval?

The FDA based the decision on adequate and well-controlled studies in adults, extrapolated to children, plus a single-dose study of how the drug behaves in the body (pharmacokinetics) in 18 patients aged 10 and older. Key points:

• Adult trials: the ONWARDS phase 3a programme included four randomised trials in about 2,680 adults with type 2 diabetes.
• Paediatric study: the open-label study (NCT05790681), run at seven US sites, enrolled 18 insulin-treated participants with a mean age of 14.4 years.
• Safety: there were six mild adverse events in two participants and one level 1 hypoglycaemic (low blood sugar) episode, with no serious adverse events.
• Absorption: children absorbed the first dose faster than adults, but the FDA said modelling showed blood levels become similar to those in adults after the first few doses.

Contemporary Pediatrics noted limits: the paediatric data cover only 18 patients on a single dose, all already on insulin and with obesity, so results may not apply to every child. The study was funded by Novo Nordisk, and long-term paediatric outcomes await post-marketing data.

Who Can Use It, and What Are the Risks?

Safety and effectiveness have not been established in children under 10, and the approval does not cover type 1 diabetes. Because Awiqli is a concentrated U-700 product dosed differently from other injectable diabetes treatments, the label stresses careful dose selection and pen-label checks to prevent errors. Common side effects listed by Novo Nordisk include hypoglycaemia, allergic reactions, injection-site reactions, skin thickening or pits at injection sites, itching, rash, swelling of the hands and feet, and weight gain.

Why Does It Matter for Children With Type 2 Diabetes?

Type 2 diabetes is increasingly being diagnosed in young people. Projections cited by Contemporary Pediatrics estimate that 30,000 to 84,000 US young people could be living with the condition by 2050. “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, professor of paediatrics at the University of California, San Francisco, in Novo Nordisk’s announcement.

Families should discuss any change to insulin treatment with their child’s diabetes care team. This article is for information only and is not medical advice. For more health news, read our reports on the FDA’s Jemperli approval for rectal cancer and US measles cases, and our guides on how much protein you need per day and intermittent fasting for beginners.

Featured image: Marius Vassnes / Wikimedia Commons, CC BY-SA 4.0. An insulin pen; illustrative photo, not Awiqli. Image licensed CC BY-SA 4.0.

Sources

• US Food and Drug Administration — FDA approves first once-weekly insulin for type 2 diabetes mellitus in pediatric patients (23 October 2026).
• Novo Nordisk — FDA Approves Pediatric Awiqli Therapy (23 October 2026).
• Contemporary Pediatrics — FDA approves once-weekly insulin icodec for pediatric T2D (October 2026).