FDA approves the first once-weekly insulin for children with type 2 diabetes

The US Food and Drug Administration on 23 October 2026 approved Awiqli (insulin icodec-abae) from Novo Nordisk for children aged 10 and older with type 2 diabetes, as an adjunct to diet and exercise. The FDA lists it as the first once-weekly insulin approved for type 2 diabetes in paediatric patients.

What changes

Awiqli is a long-acting basal insulin injected once a week on the same day, instead of daily — cutting basal injections from seven a week to one. It was already approved for adults in the US (in March 2026, as we reported earlier) and in the EU and other countries. Novo Nordisk points to rising rates of type 2 diabetes among young people as a reason families need simpler options.

The evidence and its limits

• According to Novo Nordisk, the approval is based on adequate and well-controlled trials in adults (the ONWARDS programme) plus a single-dose pharmacokinetic study in patients aged 10 to under 18.
• In other words, there was no large, dedicated efficacy trial in children; effectiveness in this age group is extrapolated from adult data and drug-level measurements.
• Listed common side effects include hypoglycaemia (low blood sugar), injection-site reactions, lipodystrophy, rash, swelling of hands and feet, and weight gain; serious allergic reactions are possible.

Decisions on switching insulin should be made with the child’s diabetes care team.