Danish pharmaceutical company Novo Nordisk A/S (CPH:NOVO-B) (NYSE:NVO) announced on Thursday that it has received approval from the US Food and Drug Administration (FDA) for Awiqli (insulin icodec-abae) 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 (blood sugar) in adults living with type 2 diabetes..

According to Novo Nordisk, this new approval offers the only once-weekly basal insulin option, an alternative to daily basal insulin injections, recognising the importance of personalised care and the need for treatments that fit different patient routines and preferences.

This approval is based on results from the ONWARDS type 2 diabetes phase 3a programme for once-weekly Awiqli 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 vs. daily basal insulin and demonstrated efficacy in the primary endpoint of reduction of A1C across the ONWARDS pivotal clinical trial programme for adults with type 2 diabetes. The safety profile for Awiqli was overall consistent with the daily basal insulin class.