Overview
- FDA approval makes Novo Nordisk’s Awiqli the first long-acting basal insulin dosed once a week for adults with type 2 diabetes as an add-on to diet and exercise.
- The decision is supported by ONWARDS Phase 3a data from four active-controlled trials in about 2,680 adults that showed reductions in HbA1c compared with daily basal insulin.
- Across the ONWARDS studies, safety was overall consistent with the known profile of basal insulin according to the company.
- Patients take Awiqli on the same day each week using a prefilled FlexTouch pen that delivers a U-700 concentration.
- Novo Nordisk plans a U.S. launch in the second half of 2026 using the FlexTouch device, and the therapy already has approvals in the European Union and 13 other countries.