- FDA approved Awiqli (insulin icodec-abae) 700 units/mL as the first once-weekly basal insulin for adults with type 2 diabetes.
- ONWARDS phase 3a comprised ~2,680 adults across four randomized, active‑controlled, treat‑to‑target trials showing HbA1c reductions versus daily basal insulin.
- Novo Nordisk plans a US nationwide launch in H2 2026; Awiqli is already approved in the EU and 13 additional countries.
- Awiqli is administered once weekly via the FlexTouch device, reducing basal injections from seven to one per week, with a safety profile overall consistent with the daily basal insulin class.
FDA approval and indication
The FDA approved Awiqli (insulin icodec-abae) injection 700 units/mL as the first once-weekly, long-acting basal insulin, indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes.
Clinical evidence
Approval was based on the ONWARDS phase 3a programme, comprising four randomized, active-controlled, treat-to-target trials in ~2,680 adults with uncontrolled type 2 diabetes; once-weekly Awiqli showed HbA1c reductions versus daily basal insulin, with a safety profile overall consistent with the daily basal insulin class.
Administration and availability
Awiqli is administered once weekly on the same day each week using the FlexTouch device, reducing basal injections from seven to one per week; Novo Nordisk expects a US nationwide launch in H2 2026 and the medicine is already approved in the EU and 13 additional countries.
