Novo Nordisk (NYSE:NVO) today announced that the U.S. Food and Drug Administration (FDA) has approved Awiqli® (insulin icodec-abae), the first and only once-weekly, long-acting basal insulin for adults living with type 2 diabetes.
The regulatory milestone represents the most significant innovation in basal insulin delivery in decades, offering a treatment solution that reduces the injection burden from daily to weekly while maintaining rigorous glycemic control.
The FDA approval is supported by the comprehensive ONWARDS Phase 3a clinical programme, which included four randomized, active-controlled trials involving approximately 2,680 adults with uncontrolled type 2 diabetes.
Across the pivotal studies, once-weekly Awiqli® met its primary endpoint of HbA1c reduction, demonstrating non-inferiority and, in some cases, superior blood sugar lowering compared to leading daily basal insulins.
The safety profile remained consistent with the established daily basal insulin class, providing a reliable transition for patients currently on daily regimens.
Awiqli® is indicated as an adjunct to diet and exercise to improve glycemic control and can be used in combination with mealtime insulin, oral anti-diabetic agents, or GLP-1 receptor agonists.
The product has already secured approvals in the European Union and 13 other countries.
Novo Nordisk expects to launch the therapy in the U.S. using its proprietary FlexTouch® device in the second half of 2026.