The US Food and Drug Administration approved insulin icodec-abae (Awiqli) injection as the first once-weekly basal insulin indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

The treatment reduces injections from seven to one per week and is administered once weekly on the same day using the Awiqli FlexTouch device.

The approval was based on results from the ONWARDS phase 3a program, which comprised four randomized, active-controlled, treat-to-target trials in approximately 2,680 adults with uncontrolled type 2 diabetes. In these trials, once-weekly insulin icodec-abae was used in combination with mealtime insulin or with oral antidiabetic agents and/or glucagon-like peptide-1 receptor agonists. The clinical program evaluated once-weekly insulin icodec-abae versus daily basal insulin and demonstrated efficacy in the primary endpoint of HbA1c reduction. Across the ONWARDS trials, the safety profile was overall consistent with the daily basal insulin class.

Awiqli has received regulatory approval in the US, the EU, and 13 other countries, with indications varying by market for diabetes treatment. Novo Nordisk indicated that a US launch is anticipated in the second half of 2026, with the therapy to be delivered via the FlexTouch device.

Source: Novo Nordisk