FDA Approves Once Weekly Insulin for Children With Type 2 Diabetes

The FDA has approved Awiqli (insulin icodec abae) for pediatric patients aged 10 years and older with type 2 diabetes mellitus, according to an FDA announcement. The drug is a long acting insulin analog given by subcutaneous injection once a week, intended as an adjunct to diet and exercise. Awiqli was approved for adults with the same condition earlier this year, and this clearance makes it the first once weekly insulin available for children with type 2 diabetes.

Approval was supported by a single dose pharmacokinetic study in 18 pediatric patients. Researchers found that children absorbed the first dose faster than adults, but pharmacometric modeling indicated that blood levels equalized with adult levels after the first few doses. Based on that modeling, the agency expects Awiqli to lower blood glucose in children in a manner similar to adults.

The safety profile mirrors other insulin products, with hypoglycemia as the most common risk, along with hypersensitivity reactions, injection site changes, itching, rash, swelling, and weight gain. Because dosing differs from other insulins, the label warns patients to check the dose on the FlexTouch pen before every injection to avoid errors or accidental overdose.

This is an approved prescription medication, not a research compound, and any use should be guided by a prescribing clinician.

This article is for education only. It is not medical advice. Compounds discussed here are sold for research purposes. Talk to a licensed clinician before making health decisions.