First once-weekly insulin Icodec-abae approved for Type 2 diabetes -

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 mellitus

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, randomized, 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:
- With mealtime insulin, or
- With oral antidiabetic drugs and/or GLP-1 receptor agonists
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.