7/103 sources · 3 publishersUpdated Oct 23, 21:22 UTC
FDA approves Novo Nordisk’s Awiqli as first once‑weekly basal insulin for children 10 years and older
Novo Nordisk announced that the U.S. Food and Drug Administration approved Awiqli® (insulin icodec‑abae) 700 U/mL as a once‑weekly basal insulin for children aged 10 years and older with type 2 diabetes. The decision follows adult data and a pediatric pharmacokinetic study, making Awiqli the first and only insulin of its kind for this age group. The product will be sold through more than 70,000 U.S. pharmacies.
Why it matters
The new pediatric indication expands Novo Nordisk’s addressable market and could drive additional sales as the prevalence of type 2 diabetes in youth rises, according to the company’s press release.
Key facts
- 1The FDA approved Awiqli® (insulin icodec‑abae) 700 U/mL for children 10 years and older with type 2 diabetes. prnewswire.com
- 2Awiqli is the first once‑weekly basal insulin approved for this pediatric population. healio.com
- 3Approval was based on adult ONWARDS trial data and a single‑dose pharmacokinetic study in children aged 10‑17 years. healio.com
- 4Awiqli will be available at more than 70,000 pharmacies nationwide. prnewswire.com
- 5The approval was announced on Oct. 23 2026. prnewswire.com
Summary written by AlphAI AI Desk from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.