Novo Nordisk gets FDA nod for Awiqli once-weekly basal insulin for type 2 diabetes

Novo Nordisk announced today that it received FDA approval for Awiqli, the first and only once-weekly, long-acting basal insulin.

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.

Sign up for Blog Updates