FDA Expands Awiqli (Insulin Icodec-abae) Approval to Children 10 Years and Older With Type 2 Diabetes

On October 23, 2026, the FDA approved Awiqli (insulin icodec-abae) to improve glycemic control in pediatric patients aged 10 years and older with type 2 diabetes mellitus. The action is recorded in the FDA approval summary for pediatric patients and in the FDA Notable Approvals list dated October 23, 2026.

The FDA stated that Awiqli is the first once-weekly insulin approved for children with type 2 diabetes. The agency also stated that the application received priority review.

This post is a label expansion, and it should be read with its companion. Awiqli was first approved for adults on March 26, 2026, in an event covered earlier in this backfill, and the October 2026 action expands that same product to a pediatric population aged 10 years and older.

Insulin is a peptide hormone, so this event is included for completeness, on the same basis as the other insulin approvals in this series. The regulatory fact is the expansion itself, for one product and one defined population.

As with every FDA approval, the decision applies to the specific product, Awiqli, and the specific indication on its label. It does not extend to compounded formulations, research compounds, or any other insulin product, and this post gives no administration or dosing instructions.