Novo Nordisk launches Awiqli once-weekly basal insulin in US

Product and indication

Awiqli (insulin icodec-abae) injection 700 units/mL is now available in the US as the first once-weekly basal insulin approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The product is delivered via a prefilled FlexTouch pen, reducing basal injection frequency from seven daily doses to one weekly dose.

Clinical evidence

The FDA approval was based on the ONWARDS type 2 diabetes phase 3a program, which evaluated once-weekly Awiqli in adults with type 2 diabetes used with mealtime insulin or with common oral anti-diabetic agents and/or GLP-1 receptor agonists. The program comprised three randomized, open-label, treat-to-target, active-controlled trials and one randomized, double-blind, treat-to-target, active-controlled trial and demonstrated non-inferiority versus daily basal insulin for mean change in HbA1c from baseline to trial end.

Safety profile

Across five ONWARDS trials, Awiqli’s safety profile was overall consistent with the daily basal insulin class. Reported adverse events include hypoglycemia, serious allergic reactions, injection-site reactions, lipodystrophy, itching, rash, peripheral swelling, and weight gain.

Access and support

Awiqli is available at more than 70,000 pharmacies nationwide. Novo Nordisk provides a Patient Education Center and affordability offerings through NovoCare.com; eligible patients may reduce out-of-pocket costs to as little as $35 per month.