FDA Approves Once-Weekly Basal Insulin Awiqli® for Type 2 Diabetes Management

The US Food and Drug Administration (FDA) has approved Awiqli® (insulin icodec-abae) as the once-weekly basal insulin for adults with type 2 diabetes. This approval marks a major advancement in reducing treatment burden by decreasing basal insulin injections from seven to one per week.

Significant Reduction in Injection Burden

When used as an adjunct to diet and exercise to improve glycaemic control, once-weekly basal insulin offers a convenient alternative to daily dosing. Novo Nordisk expects to launch Awiqli® in the United States in the second half of 2026. The product is already approved in the European Union and 13 additional countries.

Strong Clinical Data from ONWARDS Programme

The FDA approval is based on the ONWARDS phase 3a clinical programme, which included four randomised, active-controlled trials involving approximately 2,680 adults with type 2 diabetes. These studies showed that once-weekly basal insulin achieved comparable HbA1c reductions to daily basal insulin regimens, with a safety profile consistent with the established insulin class.

This approval comes at a time when some companies have scaled back insulin development. It highlights Novo Nordisk’s ongoing commitment to insulin innovation. By using the FlexTouch® device for once-weekly administration on the same day each week, Awiqli® provides a differentiated pharmacokinetic profile designed for extended duration of action.

Implications for Adherence and Patient Outcomes

The reduction from daily to weekly injections has the potential to meaningfully improve treatment adherence and persistence. These improvements could lead to better real-world glycaemic control, fewer diabetes complications, and enhanced quality of life for patients.

From a health economics perspective, once-weekly basal insulin may deliver measurable benefits in adherence and health-related quality of life that are often underrepresented in traditional cost-effectiveness analyses. These advantages could support favourable reimbursement discussions and value-based contracting models with payers.