FDA approves once-weekly Awiqli for children aged 10 and older with type 2 diabetes
FDA approved insulin icodec-abae as an addition to diet and exercise for improving blood-sugar control in eligible pediatric patients.
What the record says
FDA’s October 23 notice identifies Awiqli as the first once-weekly insulin approved for children with type 2 diabetes. The agency describes a small pediatric pharmacokinetic study and modeling supporting expected effects similar to adults. The approval does not cover every child or every form of diabetes.
Source details and supporting locations.
Practical next step
Patients and caregivers should discuss approved treatment options with their healthcare professional and consult the current prescribing information.
Limits and what is not established
Insulin can cause severe low blood sugar. FDA also warns about medication errors and accidental overdose because this product’s dosing differs from other insulins. Do not change medicines or dosing based on this report.
Sources checked October 24, 2026. Later notices may change instructions or arrangements.
Original sources
U.S. Food and Drug Administration: original information