Novo Nordisk expands US diabetes portfolio with nationwide availability of Awiqli
The FDA approval was supported by findings from the Phase 3a ONWARDS clinical program, which evaluated once-weekly Awiqli® in adults with type 2 diabetes.
USA— Novo Nordisk has launched Awiqli® (insulin icodec-abae) injection 700 units/mL across the United States, making the once-weekly basal insulin available to eligible adults with type 2 diabetes.
The therapy received approval from the U.S. Food and Drug Administration (FDA) earlier this year as an adjunct to diet and exercise to improve blood sugar control in adults with the condition.
Expanding treatment options
According to Novo Nordisk, Awiqli® is the first once-weekly basal insulin approved in the United States, reducing the number of basal insulin injections from seven per week to just one.
The company believes this dosing schedule could help simplify diabetes management for many patients who find daily injections difficult to maintain.
“Awiqli® represents meaningful progress in the options available for basal insulin therapy for the millions of adults with type 2 diabetes,” said Tom Scales, Senior Vice President of Market Access & Public Affairs and Patient Support Solutions at Novo Nordisk.
He added that the company is focused on ensuring broad access to the therapy so eligible adults can discuss the treatment with their healthcare providers and determine whether it is appropriate for their diabetes management.
Designed to simplify diabetes care
Novo Nordisk said clinical studies have shown that simplifying treatment regimens can improve the experience of adults living with type 2 diabetes.
Daily basal insulin therapy may be challenging for some patients, and reducing injection frequency could help overcome one of the common barriers to initiating and maintaining insulin treatment.
Awiqli® is administered once a week using the prefilled FlexTouch® pen, which the company says offers a more convenient option for patients requiring basal insulin.
The simplified dosing schedule is intended to support long-term treatment adherence while maintaining effective blood sugar control.
Clinical trial results
The FDA approval was supported by findings from the Phase 3a ONWARDS clinical program, which evaluated once-weekly Awiqli® in adults with type 2 diabetes.
Participants received the therapy either alongside mealtime insulin or in combination with commonly prescribed oral diabetes medicines and/or GLP-1 receptor agonists.
The program included three randomized, open-label, treat-to-target, active-controlled trials and one randomized, double-blind, treat-to-target, active-controlled study.
Across these pivotal trials, Awiqli® demonstrated non-inferiority to daily basal insulin in reducing HbA1c levels, the primary measure of long-term blood sugar control.
Researchers also found that the overall safety profile of Awiqli® was consistent with that of daily basal insulin therapies used in the comparison studies.
Availability and patient support
Novo Nordisk said Awiqli® is now available through retail pharmacies nationwide for eligible patients.
The company also provides educational resources through its NovoCare Patient Education Center, where people living with type 2 diabetes can access disease management information, healthy recipes, and treatment support tools.
In addition, eligible patients may qualify for affordability programs that can reduce out-of-pocket costs to as little as US$35 per month, helping improve access to the new once-weekly insulin therapy.
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