On Thursday, the U.S. Food and Drug Administration (FDA) approved Novo Nordisk A/S’ (NYSE:NVO) Awiqli (insulin icodec-abae), marking the first once-weekly basal insulin for adults with Type 2 diabetes.
The company positioned the therapy as a shift in diabetes care, potentially reducing the burden of daily injections while maintaining glycemic control.
FDA Clears First Once-Weekly Basal Insulin
The newly approved treatment is indicated as an adjunct to diet and exercise to improve blood sugar levels in adults with Type 2 diabetes.
Awiqli introduces a once-weekly dosing regimen, offering an alternative to traditional daily basal insulin therapies.
“Awiqli is an important new option that meets a real need as the first FDA-approved, once-weekly basal insulin for adult patients with type 2 diabetes. It’s helping to reframe what basal insulin care can look like,” said Anna Windle, Group Vice President, Clinical Development, Medical & Regulatory Affairs at Novo Nordisk Inc.
“Awiqli may address challenges associated with the frequency of daily basal injections, by reducing them from seven to one per week. It is an important advancement for adults with type 2 diabetes who may benefit from an alternative treatment option,” Windle further added.
Clinical Data Shows Comparable Efficacy
Data from the ONWARDS Phase 3a clinical program, which included about 2,680 adults with uncontrolled Type 2 diabetes, backed the FDA’s decision.
The trials compared once-weekly Awiqli with daily basal insulin in combination with mealtime insulin or other anti-diabetic treatments.
Across studies, Awiqli met its primary endpoint by demonstrating reductions in A1C levels comparable to daily basal insulin.
The safety profile was broadly consistent with the existing basal insulin class.
Experts Highlight Adherence Benefits
Julio Rosenstock, a principal investigator in the ONWARDS program, said that while daily basal insulin has been a cornerstone of treatment for over two decades, adherence remains a challenge for some patients.
Rosenstock added that weekly injectable therapies improve adherence, suggesting Awiqli could offer patients working toward blood sugar targets a more manageable routine.
Rollout Expected in Coming Months
Novo Nordisk said Awiqli will be available across the U.S. in the coming months. The European Union and several other countries have already approved the therapy, with varying indications.
Patients administer Awiqli once weekly using a prefilled FlexTouch pen, and it is available in a U-700 concentration.
NVO Price Action: Novo Nordisk shares were up 0.41% at $36.54 during premarket trading on Friday, according to Benzinga Pro data.
Image via Shutterstock
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