Novo Nordisk (NYSE: NVO) has launched Awiqli (insulin icodec-abae) injection 700 units/mL nationally, following U.S. Food and Drug Administration approval earlier this year. The company describes it as the first once-weekly basal insulin approved to improve glycemic control in adults with type 2 diabetes, used as an adjunct to diet and exercise.

Awiqli is available at retail pharmacies nationwide, delivered via a prefilled FlexTouch pen. Eligible patients may lower out-of-pocket costs to as little as $35 per month through Novo Nordisk's affordability program.

The FDA approval was based on results from the ONWARDS phase 3a clinical program, which included three randomized, open-label trials and one randomized, double-blind trial. The program evaluated Awiqli administered once-weekly in adult patients with type 2 diabetes, used alongside mealtime insulin, oral anti-diabetic agents, and/or GLP-1 receptor agonists. The trials demonstrated non-inferiority to daily basal insulin in mean change in HbA1c from baseline.

Across five ONWARDS trials, the safety profile of Awiqli was consistent with that of daily basal insulins. Common adverse events include hypoglycemia, serious allergic reactions, injection site reactions, lipodystrophy, itching, rash, swelling of hands and feet, and weight gain.

"Awiqli reduces the frequency of daily basal injections from seven to one per week," said Tom Scales, Senior Vice President of Market Access & Public Affairs and Patient Support Solutions at Novo Nordisk.