Awiqli (insulin icodec-abae) injection 700 units/mL, is indicated as an adjunct to diet and exercise to improve glycemic control (blood sugar) in adults living with type 2 diabetes. Approval grants people with type 2 diabetes a once-weekly basal insulin option for adults to fit into their routines and preferences.
Novo Nordisk said the approval comes based on results from a program comprised of four randomized, active-controlled, treat-to-target trials. The ONWARDS program evaluated 2,680 adults with uncontrolled type 2 diabetes. Subjects used Awiqli in combination with a mealtime insulin or in combination with common oral anti-diabetic agents and/or GLP-1s. The program looked at Awiqli compared to daily basal insulin.
Findings demonstrated efficacy in the primary endpoint of HbA1c reduction across the ONWARDS trial. Safety proved consistent with the daily basal insulin class.
Novo Nordisk plans to launch Awiqli in its FlexTouch device in the U.S. in the second half of 2026. FlexTouch is a disposable, pre-filled pen with a non-extending dose button and low injection force. The company touts it as easier to perform an injection, regardless of dose.
It now has approval in the U.S., EU and 13 additional countries.
Mike Doustdar, president and CEO of Novo Nordisk, said:
“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.”
