FDA Approves Novo Nordisk's Awiqli, First Once-Weekly Basal Insulin for Type 2 Diabetes
核心洞察
The FDA has approved Awiqli (insulin icodec-abae (搜索)), the first and only once-weekly basal insulin treatment for adults with type 2 diabetes (搜索), reducing injections from seven to one per week.
The approval is based on the ONWARDS phase 3a clinical program involving approximately 2,680 adults with uncontrolled type 2 diabetes (搜索), demonstrating efficacy in A1C reduction.
Awiqli offers an alternative to daily basal insulin injections and may improve patient adherence by providing a more manageable treatment routine.
The US Food and Drug Administration has approved Awiqli (insulin icodec-abae (搜索)) injection 700 units/mL, marking a significant milestone as the first and only once-weekly basal insulin for adults with type 2 diabetes (搜索). The approval, announced by Novo Nordisk on March 26, 2026, represents a paradigm shift in diabetes management by reducing basal insulin injections from seven times per week to just once.
Clinical Evidence Supporting Approval
The FDA approval is grounded in results from the comprehensive ONWARDS type 2 diabetes (搜索) phase 3a program, which comprised four randomized, active-controlled, treat-to-target trials involving approximately 2,680 adults with uncontrolled type 2 diabetes. The clinical program evaluated once-weekly Awiqli versus daily basal insulin and demonstrated efficacy in the primary endpoint of A1C reduction across all ONWARDS pivotal trials.
"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 (搜索)," said Anna Windle, PhD, 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."
The trials tested Awiqli in combination with mealtime insulin or with common oral anti-diabetic agents and/or GLP-1 receptor agonists (搜索), providing evidence for its use across diverse treatment regimens.
Safety Profile and Administration
Across the ONWARDS trials, the safety profile of Awiqli was overall consistent with the daily basal insulin class. Common adverse events include hypoglycemia (搜索) (low blood sugar), serious allergic reactions, reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy (搜索)), itching, rash, swelling of hands and feet, and weight gain.
Awiqli is administered once weekly on the same day each week using the Awiqli FlexTouch pen. The medication is available in a single concentration of 700 units/mL (U-700) and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (搜索).
Addressing Treatment Adherence Challenges
The approval addresses a significant clinical need in diabetes management. According to Julio Rosenstock, MD, a Principal Investigator for the ONWARDS trial program and Clinical Professor of Medicine at the University of Texas Southwestern Medical Center, "Some adults living with type 2 diabetes (搜索) may still find it difficult to begin and stay on this type of daily basal insulin therapy. This underscores the need for new alternative insulin options."
Dr. Rosenstock emphasized that "research supports weekly injectable diabetes medications can be associated with improved patient adherence. Having a weekly basal insulin option like insulin icodec-abae (搜索), may reshape insulin management in adults with type 2 diabetes (搜索), giving them a routine that feels more manageable as they work toward their blood sugar goals."
Global Availability and Market Impact
Awiqli has received approval not only in the United States but also in the European Union and 13 additional countries, with market-specific indications for diabetes. The medication will be available nationwide in the US in the coming months, representing Novo Nordisk's continued commitment to advancing healthcare innovation for people living with diabetes.
The approval reflects more than two decades of evolution in basal insulin therapy. As noted in the clinical context, the introduction of daily long-acting basal insulin injections more than 20 years ago with the "treat-to-target" concept was a major contribution for adults with type 2 diabetes (搜索) needing basal insulin therapy.
Important Safety Considerations
Healthcare providers and patients should be aware of several important safety considerations. Awiqli should not be used during episodes of hypoglycemia (搜索) or in patients with known allergies to the medication. Special attention is required for dosing accuracy, as the dosage of Awiqli differs from other injectable diabetes medicines.
The medication requires careful monitoring and dose adjustments based on factors including physical activity levels, stress, diet changes, weight fluctuations, and illness. Patients must also be educated about proper injection techniques and site rotation to minimize the risk of lipodystrophy (搜索) and localized cutaneous amyloidosis.