Novo Nordisk’s Awiqli (insulin icodec) has been approved by the US FDA as the first and only once-weekly, long-acting basal insulin for adults with type 2 diabetes (T2D).
Awiqli works alongside diet and exercise to improve blood sugar control in adults with T2D.
Based on results from the ONWARDS phase 3a programme, the approval provides a new treatment solution that fits around patients’ routines and preferences.
Around 2,680 adults with uncontrolled T2D took part in the four randomised, active-controlled, treat-to-target ONWARDS trials.
In the trials, the once-weekly Awiqli injection was used in combination with a mealtime insulin or common oral anti-diabetic agents and/or GLP-1 receptor agonists.
Awiqli was compared to daily basal insulin, demonstrating efficacy in the primary endpoint of HbA1c reduction and a safety profile consistent with the daily basal insulin class.
Injected once a week on the same day, Awiqli is expected to launch in the US in the second half of 2026. The treatment has also received approval in 13 countries and the EU.
Mike Doustdar, president and CEO of Novo Nordisk, said: “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,”