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MAR 27 2026
APPROVED · 126 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 chronic condition where the body struggles to regulate blood sugar, leading to serious long-term complications like heart disease, kidney failure, and vision loss. Awiqli is a once-weekly basal insulin analog that delivers a steady, long-acting supply of insulin to help manage blood sugar levels. By reducing the required injections from daily to just once a week, this treatment could make consistent blood sugar control more manageable for people living with this disease.