FDA approves once-weekly insulin for children with type 2 diabetes

The FDA approved Awiqli, or insulin icodec-abae, as a once-weekly injection to improve blood glucose control in children aged 10 years and older with type 2 diabetes. The FDA said it is the first once-weekly insulin approved for children with the condition. It is used with diet and exercise.

The FDA said its decision drew on adult studies and a single-dose study of 18 pediatric patients. The children absorbed the first dose faster than adults, but pharmacometric modeling showed that blood levels become similar to adults after the first few doses. Based on these findings, Awiqli is expected to lower blood glucose in children in a similar way as in adults.

The FDA said hypoglycemia, or low blood sugar, is the most common adverse reaction associated with Awiqli. Other common adverse reactions include allergic reactions, injection site reactions, itching, rash, swelling and weight gain. The agency advises patients to check the product label and the dose shown on the pen before each injection because Awiqli is dosed differently than other insulins.