FDA expands weekly insulin use to children

Insulin icodec-abae offers a weekly basal insulin option for pediatric type 2 diabetes, supported by adult trials and pediatric pharmacokinetic data.

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The FDA approved once-weekly insulin icodec-abae (Awiqli) for children aged 10 years and older with type 2 diabetes as an adjunct to diet and exercise.
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The long-acting basal insulin is administered subcutaneously with a prefilled pen and reduces basal insulin injections from daily to weekly.
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Pediatric approval relied on adult phase 3 ONWARDS findings and a single-dose pharmacokinetic study of 18 patients aged 10 to younger than 18 years.
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The FDA expects similar glucose-lowering effects in pediatric and adult patients based on pharmacometric modeling, although no randomized efficacy trial was conducted in children.
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Common adverse reactions include hypoglycemia, hypersensitivity, injection-site reactions, lipodystrophy, pruritus, rash, edema, and weight gain; clinicians should ensure correct weekly dosing.

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