Novo Nordisk Secures FDA Approval For Awiqli®, First Once-Weekly Basal Insulin For Type 2 Diabetes

Novo Nordisk has received U.S. Food and Drug Administration approval for Awiqli® (insulin icodec-abae), the first once-weekly, long-acting basal insulin for adults with type 2 diabetes. The therapy is indicated as an addition to diet and exercise to help improve blood sugar control, offering a more convenient alternative to daily insulin regimens.

The approval is supported by data from the ONWARDS phase 3a clinical programme, which included four randomised, active-controlled trials involving approximately 2,680 adults with uncontrolled type 2 diabetes. Awiqli® was evaluated in combination with mealtime insulin, oral antidiabetic drugs, and GLP-1 receptor agonists, demonstrating significant reductions in HbA1c levels compared with daily basal insulin.

“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.

Across the ONWARDS trials, Awiqli® showed a safety profile consistent with the existing class of daily basal insulins, reinforcing its potential as a viable long-term treatment option. The once-weekly dosing approach is expected to improve treatment adherence and better align with patient lifestyles.

Novo Nordisk plans to launch Awiqli® in the FlexTouch® device in the United States in the second half of 2026. The therapy has already received approvals in the U.S., the European Union, and multiple other countries, though specific indications may vary by market.