Novo Nordisk says Awiql approved by FDA in type 2 diabetes patients

The company states: “Novo Nordisk (NVO) announced that the FDA has approved Awiqli injection 700 units/mL, the first and only once-weekly, long-acting basal insulin, indicated as an adjunct to diet and exercise to improve glycaemic control in adults living with type 2 diabetes. The approval offers the only once-weekly basal insulin option, providing a new treatment solution that fits different patient routines and preferences for adults living with type 2 diabetes. The approval is based on results from the ONWARDS phase 3a programme in type-2-diabetes for once-weekly Awiqli(R) injection, which comprises four randomised, active-controlled, treat-to-target trials in approximately 2,680 adults with uncontrolled type 2 diabetes, used in combination with a mealtime insulin or in combination with common oral anti-diabetic agents and/or GLP-1 receptor agonists. The clinical programme evaluated once-weekly Awiqli(R) vs daily basal insulin and demonstrated efficacy in the primary endpoint of HbA1c reduction across the ONWARDS pivotal clinical trial programme in adults with type 2 diabetes. Across ONWARDS trials, the safety profile of Awiqli(R) was overall consistent with the daily basal insulin class.”