Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved Awiqli® (insulin icodec-abae) injection 700 units/mL. It is the first and only once-weekly, long-acting basal insulin indicated as an adjunct to diet and exercise to improve glycaemic control (blood sugar) in adults living with type 2 diabetes. The approval offers a new treatment solution that fits different patient routines and preferences.
Important Instructions
- The approval is based on results from the ONWARDS phase 3a programme in type-2-diabetes.
- The programme comprised four randomised, active-controlled, treat-to-target trials in approximately 2,680 adults with uncontrolled type 2 diabetes.
- Awiqli® was evaluated in combination with a mealtime insulin or in combination with common oral anti-diabetic agents and/or GLP-1 receptor agonists.
- The clinical programme evaluated once-weekly Awiqli® vs daily basal insulin and demonstrated efficacy in the primary endpoint of HbA1c reduction.
- Across ONWARDS trials, the safety profile of Awiqli® was overall consistent with the daily basal insulin class.
- Mike Doustdar, president and CEO of Novo Nordisk, stated the approval reflects ongoing efforts to advance healthcare innovation and strengthen support for people living with diabetes, reaffirmed commitment to invest in innovation, access, and supply.
- Awiqli® is designed as an alternative to daily basal insulin.
- Awiqli® is administered once weekly on the same day each week using the Awiqli® FlexTouch® device.
- Awiqli® is now approved in the US, EU, and 13 additional countries, with market-specific indications for diabetes.
- Novo Nordisk expects to launch Awiqli® in the FlexTouch® device in the US in the second half of 2026.
