Children as young as 10 who have type 2 diabetes can now take their long-acting insulin once a week instead of every day, after the Food and Drug Administration approved Novo Nordisk’s Awiqli for pediatric use on Friday, Oct. 23.
Awiqli, known generically as insulin icodec-abae, is the first once-weekly insulin cleared for children with type 2 diabetes, the FDA said in its announcement. The agency approved it for adults with the same condition earlier this year. The new label covers patients 10 and older and calls for the drug to be used alongside diet and exercise to control blood sugar.
For families, the practical change is simple. A teenager who now takes a daily basal insulin shot could switch to one injection a week, which doctors hope will make it easier to stay on treatment.
Why does a once-weekly insulin matter for kids?
Type 2 diabetes was once considered an adult disease. It is now showing up far more often in young people. According to the Centers for Disease Control and Prevention, the rate of new type 2 diagnoses among Americans under 20 doubled from 9 per 100,000 a year in 2002 to 18 per 100,000 in 2018, an increase of about 5% a year. Most young patients are diagnosed around age 16.
The disease also tends to move faster in children than in adults, and sticking with daily medication is a known problem in this age group.
“Children with type 2 diabetes face an aggressive disease trajectory, and achieving sustained glycemic control in children with type 2 diabetes remains a major challenge,” said Dr. Eda Cengiz, a professor of pediatrics at the University of California, San Francisco, in a statement released by the company. “For more than 20 years daily basal insulin injections have been a main form of treatment in pediatric diabetes care, but children living with type 2 diabetes may face challenges staying on a daily treatment routine.”
What evidence did the FDA rely on?
The pediatric approval did not rest on a large new trial in children. Instead, the FDA looked at a single-dose study of how the drug behaves in the body in 18 patients aged 10 and older with type 2 diabetes, along with the adult data that supported the earlier approval.
Children absorbed the first dose faster than adults did, the agency said. But modeling showed their blood levels of the drug became similar to adults’ after the first few doses, so Awiqli is expected to lower blood sugar in children much as it does in grown-ups. The application received priority review.
The adult approval was built on Novo Nordisk’s ONWARDS program, four phase 3 trials in about 2,680 adults, according to a report in The American Journal of Managed Care. The trade publication also reported that the company says the drug is available at more than 70,000 U.S. pharmacies.
What are the safety concerns?
The FDA said Awiqli’s safety profile is similar to that of other insulins. The most common side effects include low blood sugar, allergic reactions, injection site reactions, changes in fat tissue where the shot is given, itching, rash, swelling and weight gain.
Low blood sugar is the main risk with any insulin, and severe episodes can cause seizures, loss of consciousness or death. The label also warns about low potassium, high blood sugar, and fluid retention and heart failure when Awiqli is combined with a class of diabetes pills called thiazolidinediones.
Dosing is the other caution. Because a weekly insulin is measured differently from daily products, the FDA said patients should always check the label and the dose shown on the Awiqli FlexTouch pen before each injection. The label includes warnings about medication errors and accidental overdose.
Can children with type 1 diabetes use it?
No. The approval is limited to type 2 diabetes, and the drug has not been shown to be safe and effective in children younger than 10. The adult label also excludes type 1 diabetes. An FDA advisory committee voted against the drug in 2024 after a trial in adults with type 1 diabetes showed higher rates of serious low blood sugar, and the agency later turned down Novo Nordisk’s first application before approving a type 2-only version this year.
What should parents do now?
Families of children already on daily basal insulin can ask their child’s diabetes doctor whether a weekly option makes sense. Switching means a new dosing plan, and doctors typically watch blood sugar closely after any change in insulin.
Cost and insurance coverage will matter as well. Whether a family’s plan covers Awiqli, and at what copay, depends on the insurer’s drug list. HNC has tracked how quickly new medicines reach patients, including a recent ICER report on new drug launch prices.
Key Takeaways
- The FDA approved Awiqli (insulin icodec-abae) on Oct. 23 for children 10 and older with type 2 diabetes.
- It is the first once-weekly insulin approved for children with type 2 diabetes, replacing daily basal shots with one a week.
- The approval relied on a study in 18 young patients plus adult trial data, and it received priority review.
- Low blood sugar is the main risk, and patients should check the pen’s dose before every injection.
- The drug is not approved for type 1 diabetes or for children under 10.
Frequently Asked Questions
What is Awiqli?
Awiqli (insulin icodec-abae) is a long-acting, or basal, insulin made by Novo Nordisk that is injected under the skin once a week.
Who can use Awiqli?
Adults and children 10 years and older with type 2 diabetes, together with diet and exercise. It is not approved for type 1 diabetes or for children younger than 10.
What are the most common side effects?
Low blood sugar, allergic reactions, injection site reactions, changes in fat tissue at the injection site, itching, rash, swelling and weight gain, according to the FDA.
Does it replace mealtime insulin?
No. Awiqli is a background insulin. Children who also need mealtime insulin should follow their doctor’s plan for those doses.
