The U.S. Food and Drug Administration has approved Awiqli (insulin icodec-abae) for children aged 10 and older with type 2 diabetes. It is a long-acting insulin given by injection under the skin once a week, used along with diet and exercise to help control blood sugar.
Earlier this year, the same medicine was approved for adults with type 2 diabetes. It is the first once-weekly insulin cleared for pediatric patients with the condition. Type 2 diabetes is a long-term illness in which blood sugar stays too high because the body does not make enough insulin or does not use it well.
Insulin normally moves glucose out of the blood and into cells, and it also reduces the amount of glucose the liver produces. Awiqli is designed to lower blood sugar across a full week between doses. Researchers tested how the drug behaves in the body in a small study of 18 children aged 10 and older with type 2 diabetes.
After the first dose, the children absorbed the insulin faster than adults do. Mathematical modelling of the data, however, showed that blood levels settle into a range similar to adults after the first few doses. On that basis, the FDA expects Awiqli to lower blood sugar in children in much the same way it does in adults.
The safety profile looks like that of other insulin products. The most common side effects are low blood sugar, allergic reactions, reactions at the injection site, changes in fat tissue under the skin, itching, rash, swelling, and weight gain. Low blood sugar is the most frequent problem with any insulin, including Awiqli. Severe drops can cause seizures, loss of consciousness, or life-threatening complications.
The labelling also carries warnings about dosing errors and accidental overdose, high blood sugar, low potassium, and fluid retention or heart failure when the medicine is taken with certain other diabetes drugs called thiazolidinediones. Because Awiqli is given on a different schedule than daily insulins, patients and caregivers are told to check the product label and the dose on the Awiqli FlexTouch pen before every injection. Full prescribing information lists all known risks. The application received priority review.
