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.