# FDA Expands Once-Weekly Insulin Approval to Children With Type 2 Diabetes

Awiqli is approved for patients aged 10 and older; FDA identifies low blood sugar among its risks.

By Will Langan | 24X7 News
Published: 2026-10-26T22:04:29.985Z
Updated: 2026-10-26T22:05:10.056Z
Section: Health
Format: News
Canonical: https://24x7news.us/articles/fda-weekly-insulin-children-type2-diabetes-october-23-2026

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

## Sources
- FDA approval notice: https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-once-weekly-insulin-type-2-diabetes-mellitus-pediatric-patients
- FDA dated drug announcements index, October 23: https://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs