The U.S. FDA has approved the first once-weekly basal insulin analog, icodec-abae (Awiqli®), developed by Novo Nordisk, for adults with Type 2 diabetes. Already approved in the EU and several countries, including Canada, Australia, and Japan, this novel therapy marks a significant step toward simplifying Insulin regimens and improving treatment adherence.
Drug Overview
- Drug Name (Generic Name): Icodec-abae
- Brand Name: Awiqli®
- Dosage Form and Strength: 700 units/mL solution for injection in a pre-filled pen
- Company: Novo Nordisk
- Approval Date: March 26, 2026
- Indication: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes
Key Highlights
- First and only once-weekly, long-acting basal insulin for type 2 diabetes
- Offers a simplified and more convenient dosing regimen compared to daily basal insulin
- Designed to improve adherence in patients requiring insulin therapy
Clinical Trial Basis
- Program: ONWARDS Clinical Trial Program
- Design: Phase 3a, Randomised, active-controlled, treat-to-target trials
- Comparators: Once-weekly insulin icodec vs daily basal insulin
- Participants: 2,680 adults with uncontrolled type 2 diabetes
- Treatment Regimens:
- Results
- Achieved non-inferiority or superiority in HbA1c reduction versus daily basal insulin
- Demonstrated consistent and sustained glycemic control across studies
Safety Highlights
Common adverse events included:
- Hypoglycemia
- Serious allergic reactions
- Injection site reactions
- Lipodystrophy (skin thickening or pits at the injection site)
- Pruritus, rash
- Peripheral edema (swelling of hands and feet)
- Weight gain
Potential Limitations
- Risk of Hypoglycemia
- Patients initiated on once-weekly insulin require thorough education on recognizing and managing hypoglycemia.
- The dose and timing of concomitant therapies, including rapid-acting or short-acting insulin and other antidiabetic agents, may need to be carefully modified to reduce the risk of hypoglycemia or hyperglycemia.
- Dependence on Glucose Monitoring
- When transitioning from daily basal insulin to once-weekly icodec-abae (Awiqli®), close glucose monitoring is strongly recommended, particularly during the initial weeks.
- Cost and Access Barriers
- High cost and limited reimbursement in several regions may restrict widespread adoption.
Clinical Takeaway
Once-weekly insulin icodec-abae offers a promising alternative to daily basal insulin, particularly for patients struggling with adherence. However, careful patient selection, dose titration, and glucose monitoring remain critical for minimizing the risk of hypoglycemia.
Further Reading
- https://www.prnewswire.com/news-releases/fda-approves-novo-nordisks-awiqli-the-first-and-only-once-weekly-basal-insulin-treatment-for-adults-with-type-2-diabetes-302726839.html
- https://www.medscape.com/viewarticle/fda-approves-first-once-weekly-insulin-type-2-diabetes-2026a10009mv
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