Awiqli® approved in the US, the first and only once-weekly basal insulin treatment for adults with type 2 diabetes

Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved Awiqli® (insulin icodec-abae) injection 700 units/mL, 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 the only once‑weekly basal insulin option, providing a new treatment solution that fits different patient routines and preferences for adults living with type 2 diabetes.

The approval is based on results from the ONWARDS phase 3a programme in type-2-diabetes for once-weekly Awiqli® injection, which comprises four randomised, active-controlled, treat-to- target trials in approximately 2,680 adults with uncontrolled type 2 diabetes, used 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 the ONWARDS pivotal clinical trial programme in adults with type 2 diabetes. Across ONWARDS trials, the safety profile of Awiqli® was overall consistent with the daily basal insulin class.

“The Awiqli® approval reflects Novo Nordisk’s ongoing efforts to advance healthcare innovation and strengthen support for people living with diabetes. As the first FDA-approved, once-weekly basal insulin for adults with type 2 diabetes, it offers an important new treatment option. At a time when parts of the industry are stepping back from insulin, we are reaffirming our commitment - continuing to invest in innovation, access, and supply for the millions of patients who rely on insulin every day,” said Mike Doustdar, president and CEO of Novo Nordisk.

Novo Nordisk expects to launch Awiqli® in the FlexTouch® device in the US in the second half of 2026. Awiqli® is now approved in the US, EU, and 13 additional countries, with market-specific indications for diabetes.