Novo Nordisk said the FDA approved Awiqli, a once-weekly basal insulin, to improve blood sugar control in children aged 10 and older with type 2 diabetes, alongside diet and exercise.
The approval makes Awiqli the first once-weekly, long-acting basal insulin approved for that pediatric population, according to the company’s October 23 announcement. The treatment reduces scheduled basal insulin injections from seven per week to one.
Awiqli contains insulin icodec-abae at a concentration of 700 units per milliliter. Its pediatric approval draws on controlled studies in adults with type 2 diabetes and a single-dose pharmacokinetic study in patients aged 10 to under 18.
The pediatric study evaluated the drug’s pharmacokinetic properties. Novo said those findings, together with efficacy and safety evidence from the pivotal ONWARDS clinical trial program, supported its use in children aged 10 and older.
The release did not provide numerical results from the pediatric study or comparative blood sugar outcomes for children receiving weekly versus daily insulin.
Reported side effects include low blood sugar, serious allergic reactions, injection-site reactions, changes in skin thickness at injection sites, itching, rash, swelling of the hands and feet, and weight gain.
The announcement comes as type 2 diabetes diagnoses among young people increase. Diet, physical activity and family support remain components of care, though some children also require medication to manage their blood sugar.
The approval provides another basal insulin dosing option for eligible children. Novo did not announce a pediatric launch date or pricing in the supplied release.
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