FDA Drugs· FDA·· 4 hours agoPickScore92
FDA Approves First Once-Weekly Insulin for Type 2 Diabetes Mellitus in Pediatric Patients
In brief
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.
Why it matters
The approval extends Awiqli to children aged 10 and older with type 2 diabetes, offering a once-weekly long-acting insulin option.
Source: FDA Drugs · fda.gov