FDA approves Novo Nordisk's once-weekly insulin Awiqli for children with type 2 diabetes
Nov 2, 2026
Novo Nordisk (NYSE: NVO) announced on Friday, October 23, 2026 that the US Food and Drug Administration (FDA) has approved Awiqli (insulin icodec-abae) 700 units/mL for children aged 10 years and older with type 2 diabetes.
What was approved
According to the company and medical media reports:
- Awiqli is approved as an adjunct to diet and exercise to improve blood sugar control in children aged 10 and older with type 2 diabetes
- it is a basal insulin taken once a week, instead of the once-daily injections used with many other basal insulins
- according to the company, it is the first once-weekly basal insulin approved for this age group in the US
- Awiqli was first approved in the US for adults with type 2 diabetes in March 2026
What the approval was based on
The FDA's decision was based on:
- studies in adults with type 2 diabetes, including the phase 3 ONWARDS trials, which compared once-weekly Awiqli with once-daily basal insulin
- a single-dose study in 18 children and adolescents aged 10 to 17 with type 2 diabetes, which looked at how the medicine is absorbed and processed in the body
According to Pharmacy Times, the paediatric study found that exposure to the medicine covered the full one-week dosing interval.
Safety
According to the reports, low blood sugar (hypoglycaemia) was the most common side effect in both children and adults. Other possible side effects listed include allergic reactions, injection-site reactions and weight gain.
What was said
Michael Radin, MD, of Novo Nordisk said the product "reduces basal insulin injections from 7 to 1 per week." Eda Cengiz, MD, a professor of paediatrics at the University of California, San Francisco, said in the company's press release that children with type 2 diabetes face an "aggressive disease trajectory."
What basal insulin is
Basal insulin is a long-acting insulin that helps control blood sugar levels between meals and overnight. Many people with type 2 diabetes who need insulin take a basal insulin once a day. Once-weekly insulins are designed to release insulin slowly over seven days, so that patients need fewer injections. Type 2 diabetes is a condition in which the body does not use insulin properly, and it can affect both adults and children.
Other once-weekly insulins
According to Healio, about a month before this approval, the FDA approved Eli Lilly's insulin efsitora alfa (Onswik) as a second once-weekly basal insulin for adults. It is not approved for children.
About Novo Nordisk
Novo Nordisk is a Danish pharmaceutical company focused on diabetes, obesity and other chronic diseases. Its products include insulins and GLP-1 medicines such as Ozempic and Wegovy. Its shares are listed in Copenhagen and, as American Depositary Receipts, in New York.
How FDA label expansions work
After a medicine is approved, a company can ask the FDA to expand its use to new groups of patients, such as children. In some cases, the FDA can accept data from adult studies together with smaller studies in children, when the disease and the way the medicine works are similar in both groups.
What to watch
Key items include the launch of Awiqli for children in the US, decisions by regulators in other countries and Novo Nordisk's next quarterly results, which are scheduled for Wednesday, November 4, according to earnings calendars.
Risks and uncertainties
New medicines may face competition, pricing pressure and changes in how they are reimbursed. Uptake by doctors and patients can be slower than expected. Pharmaceutical shares can be volatile.
What this means for investors
For Investing.one users following NVO, the expanded approval may be relevant. The information above is based on the company's announcement as reported by medical media.
Sources
- Healio: FDA approves Awiqli for children with type 2 diabetes
- Pharmacy Times: FDA approves Awiqli for children aged 10 and older with T2D
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