FDA expands Awiqli use to children with type 2 diabetes

Daily insulin injections can add to the challenges of managing type 2 diabetes in children and adolescents. On October 23, 2026, FDA approved Awiqli (insulin icodec-abae) for patients aged 10 years and older, making it the first once-weekly basal insulin available for this population. It is indicated alongside diet and exercise to improve glycemic control.

The practical advance is reducing basal insulin injections from seven to one per week. For young patients who need insulin, this offers another way to tailor treatment to family routines and potentially reduce administration barriers. Whether fewer injections translate into better adherence or sustained glucose control in children has not been established.

The approval draws on adult efficacy and safety studies from the ONWARDS program and a single-dose study evaluating how the drug is absorbed and cleared in 18 pediatric patients. Modeling predicted that insulin exposure would become similar to adult levels after the first few doses, supporting an expectation of comparable glucose-lowering effects. These findings support pediatric use but do not establish superiority over daily basal insulin in children.

Prescribing requires attention to dosing education. Awiqli is a concentrated U-700 insulin administered on the same day each week. Patients and caregivers should understand the prescribed weekly dose, check the pen label and dose counter before every injection, and continue glucose monitoring. Hypoglycemia remains a central risk, and dosing errors can cause accidental overdose.

“Offering a once-weekly basal insulin may help reduce administration barriers associated with daily insulin injections and provide clinicians and families access to more individualized care,” said Eda Cengiz, MD, MHS, professor of pediatrics at the University of California, San Francisco.

Source: Novo Nordisk. (2026 Oct 23). 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