Launch Catch-Up — Approval Announced October 23, 2026
The Food and Drug Administration approved once-weekly Awiqli insulin for children aged 10 and older with type 2 diabetes, extending an indication previously granted for adults.
The regulator's October 23 notice describes the injection as an addition to diet and exercise to improve blood-sugar control. FDA says it is the first once-weekly insulin approved for children with this condition.
The pediatric evidence included a single-dose study of 18 patients. Children absorbed the initial dose faster than adults, but mathematical modeling projected similar blood levels after several doses. FDA expects blood-sugar effects comparable to those in adults.
The approval does not remove insulin's risks. FDA identifies hypoglycemia, or low blood sugar, as its most common adverse reaction; severe episodes can cause seizures, unconsciousness or death. Other reported effects include allergic and injection-site reactions, swelling and weight gain.
The product's labeling also warns about medication errors, accidental overdose and other complications.
Sources: https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-once-weekly-insulin-type-2-diabetes-mellitus-pediatric-patients https://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs