The Priority Review

Approvals Brief

FDA approves first once-weekly insulin for type 2 diabetes in pediatric patients

Awiqli (insulin icodec-abae) is approved for children aged 10 years and older with type 2 diabetes mellitus. The drug is administered by subcutaneous injection once weekly and was approved after a priority review.

Primary source

FDA approval notification, October 23, 2026

FDA Approves First Once-Weekly Insulin for Type 2 Diabetes Mellitus in Pediatric Patients

Read the source: FDA Approves First Once-Weekly Insulin for Type 2 Diabetes Mellitus in Pediatric Patients fda.gov

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