Novo Nordisk's Awiqli Becomes First Once-Weekly Insulin Approved for Children 10 and Older With Type 2 Diabetes

Novo Nordisk said on October 23, 2026 that the US Food and Drug Administration approved Awiqli (insulin icodec-abae) injection 700 units/mL for children 10 years of age and older with type 2 diabetes, the first once-weekly basal insulin cleared for that group. The PR Newswire release carried the announcement.

What the Awiqli Approval Covers

Awiqli is indicated as an adjunct to diet and exercise to improve glycemic control in children 10 years of age and older with type 2 diabetes. The approval reduces basal injection frequency from seven times per week to one, given on the same day each week using the Awiqli FlexTouch pen. Novo Nordisk is a Denmark-headquartered pharmaceutical company that develops peptide-based therapies for diabetes, obesity, MASH, cardiovascular, haemophilia and rare endocrine diseases, serving patients in approximately 170 countries.

"Awiqli reduces basal insulin injections from seven to one per week, which may help patients find a basal insulin routine that feels more manageable," said Michael Radin, MD, executive medical director at Novo.

Eda Cengiz, MD, MHS, professor of pediatrics at the University of California, San Francisco, said children with type 2 diabetes face an aggressive disease trajectory and that sustained glycemic control in them remains a major challenge. She said a once-weekly basal insulin injection could offer new alternatives for pediatric clinical care.

The approval is supported by evidence from adequate and well-controlled studies in adults with type 2 diabetes mellitus and a single-dose pharmacokinetic study in pediatric patients aged 10 to under 18 with type 2 diabetes, along with efficacy and safety from the pivotal ONWARDS clinical trial program. Awiqli is available at more than 70,000 pharmacies nationwide, and more information can be found at awiqli.com.

Novo Nordisk's Manufacturing and Reach

According to akta.pro company records, Novo Nordisk opened an upgraded Czech manufacturing plant in June 2026, acquired from Novavax 18 months earlier for $200 million, after investing $168 million to repurpose it for supportive proteins used in next-generation diabetes and obesity treatments; the site employs 300 workers and is one of seven global manufacturing hubs. The same records show a $29 million investment to expand injection pen manufacturing at its Tianjin, China facility, building on a $556 million sterile preparation expansion revealed in 2024. Novo Nordisk has 67,900 employees in 80 countries.

Earlier Novo Nordisk Moves

On October 20, 2026, Labiotech.eu reported that Novo outlined a strategy at its September 2026 Capital Markets Day aiming to launch more than five multi-blockbuster products by 2030 and generate $23 billion in risk-adjusted pipeline sales by 2035. On October 20, 2026, Yahoo reported that CagriSema led to an average 25% weight loss in women with obesity or overweight after 68 weeks in a late-stage study, based on data from 2,309 women in the REDEFINE 1 trial, with placebo showing 3% loss. On October 16, 2026, Het Financieele Dagblad reported that criminals stole thousands of insulin pens and an unknown amount of waste medication from a Dutch wholesaler, and that Novo Nordisk warned the insulin could be sold as waste medication, which is dangerous for people without diabetes.

What Comes Next for Awiqli

Awiqli is approved in the US, EU and 18 additional countries, with market-specific indications for diabetes. It is not known if Awiqli is safe and effective in children less than 10 years of age.