FDA approves once-weekly Awiqli for children 10 and older with type 2 diabetes
The FDA approved Awiqli, a once-weekly insulin, for pediatric patients aged 10 years and older with type 2 diabetes mellitus, based on a single-dose study in 18 pediatric patients. Pediatric patients now have an approved once-weekly insulin, the FDA said.
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The FDA approved Awiqli (insulin icodec-abae), injected once weekly, for pediatric patients aged 10 years and older with type 2 diabetes mellitus, and said it is the first once-weekly insulin approved for children with the disease. The approval rests on a single-dose study of blood levels in 18 pediatric patients aged 10 years and older with type 2 diabetes, the FDA said. Pediatric patients with type 2 diabetes mellitus now have an approved insulin that is administered by subcutaneous injection once weekly, the FDA said.
Why it matters
Awiqli was approved for the same condition in adults earlier this year, the FDA said. The Awiqli label, revised 3/2026, states that "Awiqli is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus." That label version also states that "The safety and effectiveness of Awiqli have not been established in pediatric patients." The label says the safety of Awiqli in patients with type 2 diabetes was evaluated in five clinical trials involving 1,880 adults.
What the FDA reported
The FDA page is dated 10/23/2026. It describes the pediatric evidence as follows:
- A single-dose study investigated the pharmacokinetic properties (blood levels) of Awiqli in 18 pediatric patients aged 10 years and older with type 2 diabetes.
- The pediatric patients absorbed the first dose of Awiqli faster than adults.
- Pharmacometric modeling showed that blood levels of Awiqli become similar to blood levels in adults after the first few doses.
- The FDA said: "Based on these findings, Awiqli is expected to lower blood glucose in pediatric patients in a similar way as it does in adults."
The FDA page reports no glycemic outcome data from pediatric patients. The FDA said the application received a priority review.
Safety
The FDA said the safety profile of Awiqli is similar to that of other insulin products. The most common adverse reactions include hypoglycemia (low blood sugar), hypersensitivity (allergic) reactions, injection site reactions, lipodystrophy (changes in fat tissue at the injection site), pruritus (itching), rash, edema (swelling), and weight gain, the FDA said.
The FDA said hypoglycemia is the most common adverse reaction associated with insulin, including Awiqli. Severe hypoglycemia can cause seizures, unconsciousness, life-threatening complications, or death, the FDA said.
The FDA said the labeling also includes warnings and precautions for medication errors and accidental overdose, hyperglycemia (high blood sugar), hypokalemia (low potassium levels), and fluid retention and heart failure when used with thiazolidinediones (another medicine approved for type 2 diabetes).
Dosing and administration
The FDA noted that Awiqli is dosed differently than other insulins. The adult label, revised 3/2026, sets separate starting doses for people new to insulin and for people switching from a daily basal insulin.
The adult label lists two contraindications: during episodes of hypoglycemia, and in patients with hypersensitivity to insulin icodec-abae or any of the excipients. The FDA page does not state a pediatric starting dose.