FDA extends weekly insulin icodec to children with type 2 diabetes

The US Food and Drug Administration has approved insulin icodec (Awiqli), Novo Nordisk's once-weekly basal insulin, for children aged 10 and over with type 2 diabetes. The company announced the decision on 23 October 2026, describing Awiqli as the first and only once-weekly insulin for this age group in the US. It is indicated alongside diet and exercise to improve blood sugar control.

The approval cuts the number of basal insulin injections a patient needs from seven a week to one. Novo Nordisk said the product, a 700 units/mL formulation given with its FlexTouch pen, is available in more than 70,000 US pharmacies.

A long road for the adult licence

The paediatric decision extends an adult type 2 diabetes indication that the FDA granted in March 2026, according to reports in AJMC and Contemporary Pediatrics. That approval came after a difficult earlier review. In May 2024 an FDA advisory committee voted against approval, citing higher rates of serious hypoglycaemia among adults with type 1 diabetes in the ONWARDS 6 trial. In July 2024 the agency issued a complete response letter that, AJMC reports, related to manufacturing and the type 1 indication. The US label for both adults and children excludes type 1 diabetes.

What the paediatric evidence consists of

The FDA did not require a dedicated paediatric efficacy trial. Efficacy is extrapolated from the adult ONWARDS phase 3a programme: four randomised, active-controlled, treat-to-target trials in about 2,680 adults with type 2 diabetes. In insulin-naive adults, weekly icodec produced larger reductions in HbA1c than daily insulin glargine U100 at 52 weeks and than insulin degludec at 26 weeks, according to Contemporary Pediatrics.

The bridge to children is a pharmacokinetic study published in Pediatric Diabetes in April 2025 by Michelle Van Name and colleagues. The open-label study enrolled 18 insulin-treated participants aged 10 to under 18 at seven US sites. Their mean age was 14.4 years, mean body mass index 38.5 and mean HbA1c 7.5%. Each received a single subcutaneous dose of 5.6 U/kg, with sampling to day 35.

Exposure, extrapolated to steady state, appeared to cover the full one-week dosing interval. It was somewhat higher than in adults: Contemporary Pediatrics reports a geometric mean area under the curve of 819 compared with 682 × 10⁵ pmol·h/L in adults. The investigators attributed the difference partly to puberty-related insulin resistance and higher body mass, and judged it of limited clinical relevance because the dose is titrated.

On safety, six mild adverse events occurred in two participants, all of which resolved, along with one level 1 hypoglycaemic episode. There were no serious adverse events, hypersensitivity reactions or injection-site reactions.

The limits of a small study

The data set is thin, and the trade press has said so. Participants received one fixed dose; pharmacodynamics were not assessed; all were already on insulin and had obesity. Novo Nordisk funded the study, and several authors are company employees. None of this is unusual for a paediatric extension built on extrapolation, which the FDA accepts where disease course and drug response are judged similar enough between adults and children. It does mean that dosing experience in younger, leaner or insulin-naive adolescents will accumulate after approval rather than before it.

The label states that safety and effectiveness have not been established in children under 10. Labelled adverse reactions include hypoglycaemia, injection-site reactions, lipodystrophy, pruritus, rash, peripheral oedema and weight gain, with warnings on hypokalaemia and on heart failure when used with thiazolidinediones. A missed dose may be taken within four days.

Why it matters

Youth-onset type 2 diabetes remains relatively uncommon, but its prevalence is projected to grow. Projections cited by the study authors suggest between 30,000 and 84,000 young people in the US could have the disease by 2050. The authors also report that medication adherence in this group declines over time, which is the main clinical argument for a weekly product.

"Children with type 2 diabetes face an aggressive disease trajectory," said Eda Cengiz, professor of paediatrics at the University of California, San Francisco, in Novo Nordisk's announcement. She said the approval "could provide new alternatives for pediatric clinical care".

For the industry, the decision is another example of a regulator accepting a modest pharmacokinetic package for a paediatric label where the adult evidence is large. Novo Nordisk said Awiqli is also approved in the EU and 18 other countries; it did not say whether those approvals cover children.

Sources

• 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 (Novo Nordisk via PR Newswire, 23 October 2026)
• FDA Extends Once-Weekly Insulin to Youth With Type 2 Diabetes (AJMC, 23 October 2026)
• FDA approves once-weekly insulin icodec for pediatric T2D (Contemporary Pediatrics, 23 October 2026)
• Van Name M et al. Pharmacokinetic Properties of Once-Weekly Insulin Icodec in Children and Adolescents With Type 2 Diabetes. Pediatric Diabetes, 2025