FDA Approves Novo Nordisk Awiqli for Type 2 Diabetes in Children and Adolescents Aged 10 and Older

In the long-acting basal insulin space, once-weekly formulations have been a recent focus of competition. Novo Nordisk's insulin icodec (Awiqli) was approved by the FDA on March 26, 2026 for adults with type 2 diabetes, as an adjunct to diet and exercise to improve glycemic control , based on the ONWARDS type 2 diabetes phase 3a program comprising four randomized, active-controlled trials . Related phase 3 studies are visible in the registry, such as NCT04760626 comparing icodec with the DoseGuide app versus once-daily basal insulin analogues (planned enrollment 1085, primary endpoint change in HbA1c at week 52), and NCT06340854 switching from daily basal insulin to icodec versus insulin glargine U100 (412 participants, primary endpoint HbA1c change at week 26) . In pediatrics, no once-weekly basal insulin had been approved before this.

The core facts of this news: the FDA recently approved Awiqli injection for children and adolescents aged 10 and older with type 2 diabetes, to improve glycemic control alongside diet and exercise. This is a pediatric extension following the March 2026 adult approval. The approval relies mainly on adequate and well-controlled studies in adults with type 2 diabetes and a single-dose pharmacokinetic study in 18 pediatric patients aged 10 to under 18 — absorption after the first dose was faster in pediatric patients than adults, but modeling showed blood concentrations similar to adults after the initial doses, with expected glucose-lowering similar to adults. Administration is once-weekly subcutaneous injection, reducing annual basal insulin injections from 365 to 52. The FDA itself confirmed Awiqli as a once-weekly insulin approved for children, having been approved earlier this year for the same condition in adults (needs verification).

This step advances both the patient population and the dosing frequency: the adult indication was approved on March 26, 2026 under BLA 761326, proper name insulin icodec-abae , with the adult indication already approved in markets including the US, Europe and China under the brand name "诺和期"; this pediatric extension takes icodec from the adult market into patients aged 10 and older, and the FDA notes it as a newly added pediatric option in the once-weekly insulin category that previously had no pediatric approval . Notably, the reduced injection frequency applies only to basal insulin and does not mean patients can stop other glucose-lowering therapy or blood glucose monitoring; the label lists common adverse reactions including hypoglycemia, hypersensitivity, injection-site reactions, lipodystrophy, pruritus, rash, edema and weight gain, plus warnings on medication errors and accidental overdose, hyper- or hypoglycemia from regimen changes, hypokalemia, and fluid retention and heart failure risk when combined with thiazolidinediones. Meanwhile, Lilly's Onswik (Efsitora alfa) had previously been approved for adults with type 2 diabetes, so the competitive landscape in pediatric once-weekly formulations warrants tracking (needs verification)。

Information not yet disclosed includes: details of the clinical data supporting this pediatric extension (whether any data beyond the 18-patient single-dose PK study), the specific dose-titration scheme in the label, and long-term safety data in pediatric patients — all to be confirmed. Future milestones to watch include publication of the full FDA label, real-world usage data in pediatric patients, and competitors' development progress in pediatric populations. This is an informational interpretation only and does not constitute investment advice (needs verification).