A new once-weekly insulin has been approved in the United States for children aged 10 years and older living with type 2 diabetes, offering an alternative to basal insulin treatments that may require injections every day.
The U.S. Food and Drug Administration (FDA) approved Awiqli, also known as insulin icodec-abae, for improving blood sugar control in paediatric patients with type 2 diabetes. According to the agency, it is the first once-weekly insulin approved in the U.S. for this group.
The latest decision expands the use of the medicine, which had previously been approved for adults with diabetes. Unlike daily basal insulin, Awiqli is designed to provide insulin coverage across an entire week. It is administered as an injection once every seven days, potentially reducing the number of basal insulin injections required over time.
The FDA based its decision on evidence that included a clinical trial involving children and adolescents with type 2 diabetes. Participants receiving the once-weekly insulin achieved reductions in blood sugar levels that supported its use for glucose control.
What the Approval Means for Diabetes Treatment
Managing type 2 diabetes can involve several measures, including changes in diet and physical activity, blood glucose monitoring and medication. For patients who require insulin, maintaining a regular injection schedule is an important part of keeping blood sugar within an appropriate range.
A once-weekly option could therefore reduce the frequency of basal insulin injections for eligible patients. However, less frequent dosing does not remove the need for careful diabetes management or medical supervision.
The FDA identifies hypoglycaemia, or low blood sugar, as the most common adverse reaction associated with Awiqli. Severe hypoglycaemia can be dangerous, making appropriate dosing and blood glucose monitoring particularly important.
The medicine is not intended for treating diabetic ketoacidosis, a potentially life-threatening complication of diabetes. Patients and caregivers should also follow healthcare professionals’ instructions when using insulin and should not alter treatment schedules without medical guidance.
For Nigerian families, the FDA decision should not be interpreted as approval for the medicine to be marketed locally. Medicines require appropriate regulatory authorisation before they can be marketed in Nigeria.
Nevertheless, the approval represents a notable development in efforts to make insulin treatment less frequent for children and adolescents with type 2 diabetes who require basal insulin.
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