- Novo Nordisk A/S NVO has completed posting topline results across its six Phase 3a clinical trials in the ONWARDS program of once-weekly insulin icodec in people with diabetes.
- In ONWARDS 5 study, once-weekly insulin icodec was found to be non-inferior to once-daily basal insulin in reducing HbA1c. With that, the 52-week open-label trial met its primary endpoint at the end of the study.
- Novo’s icodec led to a reduction of -1.68% points on HbA1c, compared to -1.31% for the once-daily control. The study comprised 1,085 insulin-naive people with type 2 diabetes. Patients on icodec also used an app to guide their dosing.
- The news adds to ONWARDS trial readouts dating back to April.
- In July, the company announced headline results from the ONWARDS 3 and ONWARDS 4 Phase 3a trials with once-weekly insulin icodec.
- Earlier this month, Novo picked up worldwide marketing rights to Zealand Pharma A/S’s ZEAL diabetes treatment Zegalogue and inked a $1.1 billion buyout of Forma Therapeutics Holdings Inc FMTX for its sickle cell drug.
- Novo Nordisk expects to file for regulatory approval of once-weekly insulin icodec in the U.S., the EU, and China in 1H of 2023.
- Price Action: NVO shares are up 2.26% at $101.88 on the last check Monday.