Key highlights
- Novo Nordisk resubmitted Awiqli® to the FDA on Sept. 29, 2025.
- Awiqli® is a once-weekly basal insulin for type 2 diabetes.
- The ONWARDS program involved 5 trials with 4,000 adults.
- Awiqli® is approved in the EU and 12 other countries.
Resubmission to FDA
Novo Nordisk has resubmitted its Biologics License Application for Awiqli® (insulin icodec) to the US FDA. This once-weekly basal insulin aims to provide an alternative to daily injections for adults with type 2 diabetes.
Clinical Trials
The resubmission is based on the ONWARDS phase 3a clinical program, which included five randomized, active-controlled trials involving approximately 4,000 adults with type 2 diabetes. The primary endpoint was the change in A1C levels from baseline.
Regulatory Status
Awiqli® is already approved in the European Union and 12 other countries. Additional regulatory filings have been completed in several other countries, with further decisions expected in 2025.
