The US Food and Drug Administration (FDA) has approved insulin icodec-abae (Awiqli), the first once-weekly basal insulin for children aged 10 years and older with type 2 diabetes, expanding treatment beyond adults and reducing the required frequency of basal insulin injections from daily to weekly.
The long-acting insulin analog is approved as an adjunct to diet and exercise to improve glycemic control. Administered subcutaneously using a prefilled pen, it provides an alternative to daily basal insulin injections. The drug received initial FDA approval for adults earlier this year.
The pediatric approval was supported by efficacy and safety findings from the phase 3 ONWARDS clinical program in adults with type 2 diabetes, alongside a single-dose pharmacokinetic study involving 18 pediatric patients aged 10 to younger than 18 years.
The adult program included randomized, active-controlled trials comparing once-weekly insulin icodec-abae with daily basal insulin regimens, including insulin glargine and insulin degludec. Glycemic control was assessed primarily by changes in glycated hemoglobin levels.
In the pediatric study, insulin icodec-abae was absorbed more rapidly after the initial dose than in adults. However, pharmacometric modeling indicated that insulin were comparable in pediatric and adult patients after several doses.
Based on these findings, the FDA concluded that insulin icodec-abae is expected to provide similar glucose-lowering effects in pediatric patients. The pediatric approval was not supported by a separate randomized efficacy trial in children.
According to the FDA, the treatment's safety profile is similar to that of other insulin products. Common adverse reactions include hypoglycemia, hypersensitivity reactions, injection-site reactions, lipodystrophy, pruritus, rash, edema, and weight gain.
Severe hypoglycemia may cause seizures, loss of consciousness, life-threatening complications, or death. Additional warnings include medication errors, accidental overdose, hyperglycemia, hypokalemia, and fluid retention or heart failure when used with thiazolidinediones.
Insulin icodec-abae is supplied as a 700-unit/mL formulation in a FlexTouch prefilled pen. Because its concentration and weekly dosing differ from conventional insulin regimens, the FDA recommends that clinicians should ensure patients and caregivers understand dose selection and administration. The pen's dose counter must be checked before each injection, and insulin must not be withdrawn from the pen using a syringe.
The pediatric application received FDA Priority Review. Dosing should be individualized based on glucose monitoring results, metabolic requirements, and glycemic goals, with close monitoring during treatment initiation or transitions from daily basal insulin.
Source: FDA, Novo Nordisk, Prescribing information