On Oct. 23, 2026, the U.S. Food and Drug Administration announced it has approved Awiqli (insulin icodec-abae) injection, a long-acting insulin analog, as an adjunct to diet and exercise to improve glycemic control in pediatric patients aged 10 years and older with type 2 diabetes mellitus. Awiqli is administered by subcutaneous (under the skin) injection once weekly. Awiqli, which was approved for the same condition in adults earlier this year, is the first once-weekly insulin to be approved for children with type 2 diabetes mellitus.

Type 2 diabetes mellitus is a chronic disease in which blood glucose (blood sugar) levels are too high because the body does not make enough insulin or does not use insulin effectively. Insulin helps regulate blood glucose by helping glucose move from the blood into cells and by reducing the amount of glucose produced by the liver. Awiqli lowers blood glucose over a weekly dosing interval.

The most common adverse reactions associated with Awiqli 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. 

Hypoglycemia is the most common adverse reaction associated with insulin, including Awiqli. Severe hypoglycemia can cause seizures, unconsciousness, life-threatening complications, or death. The labeling for Awiqli 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). 

Because Awiqli is dosed differently than other insulins, patients should always check the product label and the dose shown on the Awiqli FlexTouch pen before each injection to make sure they are taking the right amount. See the full prescribing information for all risks associated with Awiqli. 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; however, pharmacometric modeling (a type of mathematical analysis) showed that blood levels of Awiqli become similar to blood levels in adults after the first few doses. Based on these findings, Awiqli is expected to lower blood glucose in pediatric patients in a similar way as it does in adults.