FDA grants Awiqli pediatric approval as first weekly insulin for children with type 2 diabetes

The Awiqli pediatric approval issued in SILVER SPRING, MD, on October 23 makes insulin icodec the first once weekly insulin for children aged 10 and older with type 2 diabetes, the Food and Drug Administration said. Novo Nordisk sells the drug as Awiqli, and the agency approved it for adults with type 2 diabetes in March 2026. The decision for children rests on adult trials and one small blood level study, not on a pediatric efficacy trial. Here is what the FDA cleared, what the evidence shows and where the gaps remain.

What the FDA approved for children

The FDA said Awiqli is a long acting insulin analog given by injection once a week. The new indication covers patients aged 10 years and older with type 2 diabetes, as an add on to diet and exercise to improve blood sugar control. The agency cleared the same drug for adults with type 2 diabetes in March 2026, and the pediatric application received priority review, the FDA said. Insulin is a peptide hormone, and icodec is an engineered analog that lowers blood glucose across a weekly dosing interval, according to the agency. Novo Nordisk, the maker, said the drug cuts basal insulin shots from seven a week to one. AJMC reported that safety and effectiveness have not been established in children younger than 10.

The Awiqli pediatric approval targets a group that is hard to treat, according to clinicians quoted by the company. Type 2 diabetes in children is rising, and Novo Nordisk cited a modeling study projecting nearly 84,000 people aged 19 or younger with the disease in the United States by 2050. The study authors behind the pediatric data also noted that adherence to diabetes medicine tends to fall over time in young patients, AJMC reported. "Children with type 2 diabetes face an aggressive disease trajectory," said Eda Cengiz, a professor of pediatrics at the University of California, San Francisco, in the company announcement. She said daily basal injections have been a main treatment for more than 20 years. Whether weekly dosing improves adherence or long term control in children has not been tested in a trial.

How an 18 patient pharmacokinetic study carried the case

The FDA said its decision drew on a single dose pharmacokinetic study in 18 pediatric patients aged 10 years and older with type 2 diabetes. Children absorbed the first dose faster than adults did, the agency said. Mathematical modeling then showed that blood levels in children become similar to adult levels after the first few doses. On that basis, the FDA said Awiqli is expected to lower blood glucose in children much as it does in adults. The FDA based its expectation of benefit in children on blood level modeling, not on a pediatric trial that measured blood sugar outcomes. Novo Nordisk said the approval also relies on well controlled studies in adults, including its ONWARDS clinical trial program.

The FDA based its expectation of benefit in children on blood level modeling, not on a pediatric trial that measured blood sugar outcomes.

AJMC, citing the published study, reported that the 18 participants were already treated with insulin and were enrolled at 7 US sites. Their mean age was 14.4 years and their mean HbA1c was 7.5%. Each participant received one fixed, weight based amount of the drug. Six adverse events occurred in 2 participants, all mild and resolved, with one level 1 low blood sugar episode and no serious events, the outlet said. The authors noted that the study did not assess pharmacodynamics, meaning it did not track how the drug changed glucose over time. Overall exposure ran slightly higher in the young patients than in adults. The authors suggested puberty related insulin resistance and higher body weight may explain that gap, AJMC reported.

Hypoglycemia risk and dosing errors on the label

The FDA said the safety profile of Awiqli is similar to that of other insulin products. The agency listed the most common adverse reactions as hypoglycemia, allergic reactions, skin reactions where the shot is given, changes in fat tissue under the skin, itching, rash, swelling and weight gain. Hypoglycemia, or low blood sugar, is the most common adverse reaction to any insulin, including this one, the FDA said. Severe episodes can cause seizures, unconsciousness, life threatening complications or death. That risk shaped the drug's earlier review history in adults with type 1 diabetes. In children, the pediatric study exposed each participant to only one dose, so it cannot show how often low blood sugar occurs over months of weekly use.

The label also carries warnings for medication errors and accidental overdose, high blood sugar, low potassium, and fluid retention and heart failure when used with thiazolidinediones, a class of type 2 diabetes drugs, according to the FDA. Because Awiqli is dosed differently from daily insulins, the agency said patients should check the product label and the dose shown on the pen before every injection. That warning matters for families moving a child from a daily product to a weekly one, where a mistake carries over a full week. The FDA directed readers to the full prescribing information for all risks. This report is for research and news purposes and is not medical advice; dosing decisions belong with a treating clinician.

Insulin icodec history and what comes next

Insulin icodec reached children after a slow path through the FDA. In May 2024, an FDA advisory committee voted against approval over higher rates of serious low blood sugar in adults with type 1 diabetes in the ONWARDS 6 trial, AJMC reported. In July 2024, the agency issued a complete response letter that cited manufacturing and the type 1 indication, the outlet said. The adult approval followed in March 2026 and excludes type 1 diabetes, and the pediatric label is likewise limited to type 2 disease. Readers can follow other agency decisions in our regulator coverage. The table below sets out the main steps, with the source for each.

Several questions remain open after the Awiqli pediatric approval. No trial in children has yet reported glucose control or low blood sugar rates over months of weekly use, based on the documents reviewed for this story. The FDA notice did not describe any required follow up studies in children, and the Novo Nordisk release did not say whether it plans a longer pediatric trial. The company has expanded its US approvals over the past year, including the first GLP 1 pill for weight management in December 2025. For this decision, the primary source is the FDA approval notice, which explains the evidence and the label warnings in plain terms. How the drug performs in routine pediatric care is not yet known.

Conclusion

The Awiqli pediatric approval gives children aged 10 and older with type 2 diabetes their first once weekly basal insulin option in the United States. The FDA leaned on adult trials and an 18 patient pharmacokinetic study rather than a pediatric efficacy trial. Low blood sugar and dosing mistakes remain the central risks on the label. Long term data in children are not yet public, and those results will decide how widely clinicians use the drug.