FDA Approves Once-Weekly Insulin Icodec for Children Aged 10 and Older with Type 2 Diabetes
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The FDA has approved Awiqli (insulin icodec-abae), a long-acting insulin analog, as an adjunct to diet and exercise for pediatric patients aged 10 and older with type 2 diabetes. Administered by subcutaneous injection once weekly, it becomes the first once-weekly insulin approved for this population. A single-dose pharmacokinetic study in 18 pediatric patients aged 10 and older with type 2 diabetes showed the first dose was absorbed faster than in adults. However, pharmacometric modeling indicated blood levels become similar to adults after the first few doses, so a similar glucose-lowering effect is expected.
Written by a model from the reports · updated 4 hours ago
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- fda.govPickFDA Approves First Once-Weekly Insulin for Type 2 Diabetes Mellitus in Pediatric Patients
The FDA approved Awiqli (insulin icodec-abae), a long-acting insulin analog, as an adjunct to diet and exercise for children aged 10 and older with type 2 diabetes, given by subcutaneous injection once weekly. A single-dose pharmacokinetic study in 18 such children found faster absorption of the first dose than in adults, but modeling showed blood levels similar to adults after the first few doses, so a similar glucose-lowering effect is expected.
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