Novo Nordisk Wins FDA Nod for Once-Weekly Awiqli Insulin After 2,680-Patient Trials
Novo Nordisk secured FDA approval for Awiqli, a once-weekly basal insulin (700 units/mL) for adults with type 2 diabetes. Data from the ONWARDS Phase IIIa programme, spanning four treat-to-target trials in nearly 2,680 patients, demonstrated HbA1c reductions comparable to daily basal regimens.
1. FDA Approval for Awiqli
The US FDA has approved Awiqli (insulin icodec-abae) 700 units/mL as the first once-weekly basal insulin for adults with type 2 diabetes, expanding treatment options for improved glycaemic control.
2. Clinical Trial Programme
Approval was based on the ONWARDS Phase IIIa programme, which included four randomised, active-controlled, treat-to-target studies involving nearly 2,680 adults; Awiqli achieved primary HbA1c endpoints comparable to daily basal insulin regimens.
3. Commercial Launch Plans
Novo Nordisk plans to launch Awiqli using the FlexTouch device in the US in the second half of 2026; the product is already approved in the European Union and 13 additional countries with market-specific type 2 diabetes indications.