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MAR 27 2026
APPROVED · 186 DAYS AGO

Novo Nordisk — Awiqli (insulin icodec-abae) $NVO

for type 2 diabetes — once-weekly basal insulin

NDA · Standard Review

FDA approved Awiqli (insulin icodec-abae) 700 units/mL on March 27, 2026 — ~2 months ahead of the projected May 29 PDUFA. First and only once-weekly basal insulin for adults with type 2 diabetes, reducing basal injections from seven to one per week. Based on ONWARDS Phase 3a programme. Nationwide US launch expected 2H 2026.

About

Type 2 diabetes is a condition where the body stops responding properly to insulin and cannot make enough of it, leaving blood sugar too high and, over time, damaging the heart, eyes, kidneys, and blood flow to the limbs. Awiqli is a long-acting, lab-made insulin taken once a week instead of daily, delivering the same hormone the body uses to move sugar out of the bloodstream. Because it replaces that missing insulin signal with far fewer injections, it may help adults with type 2 diabetes keep blood sugar steadier while easing the daily burden of treatment.