FDA approves Novo Nordisk Awiqli, first once-weekly basal insulin for adults with type 2 diabetes

FDA approval and indication

The FDA approved Awiqli (insulin icodec-abae) injection 700 units/mL as the first once-weekly long-acting basal insulin, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

Clinical evidence

Approval was based on the ONWARDS phase 3a program comprising four randomized, active-controlled, treat-to-target trials in approximately 2,680 adults with uncontrolled type 2 diabetes, including use with mealtime insulin or with oral antidiabetic agents and/or GLP-1 receptor agonists; trials demonstrated A1C reductions versus daily basal insulin and an overall safety profile consistent with the daily basal insulin class.

Dosing and administration

Awiqli is supplied as U-700 and administered once weekly on the same day each week using the Awiqli FlexTouch pen; guidance includes not dialing the maximum single dose unless prescribed, not withdrawing with a syringe, subcutaneous injection in thigh/upper arm/abdomen, rotating injection sites, and missed-dose rules (take missed dose if ≤4 days since last dose; otherwise skip and resume on the regular day).

Safety and contraindications

Common and serious risks include hypoglycemia, severe allergic reactions, injection-site reactions, lipodystrophy, itching, rash, peripheral edema, weight gain, hypokalemia, and potential worsening of heart failure when combined with thiazolidinediones; do not use during episodes of hypoglycemia or with known allergy to the product, and inform providers about liver/kidney issues, pregnancy/breastfeeding, and concomitant medicines.

Availability

Awiqli is expected to be available nationwide in the US in the coming months and is approved in the US, EU, and 13 additional countries.