Novo Nordisk Etavopivat Phase 3 Success

Novo Nordisk announced positive topline results from its HIBISCUS phase 3 trial for Etavopivat, an oral, once-daily drug for sickle cell disease (SCD). The trial successfully met both co-primary endpoints, demonstrating a 27% reduction in vaso-occlusive crises (VOCs) and a superior improvement in haemoglobin response compared to placebo. Etavopivat also significantly prolonged the time to first VOC and reduced the risk of blood transfusion. The drug appeared well tolerated, with a safety profile consistent with previous trials. Novo Nordisk plans to submit for the first regulatory approval of Etavopivat in the second half of 2026. Etavopivat, acquired through the 2022 acquisition of Novo Nordisk===Forma Therapeutics, has received Fast Track, Rare Pediatric Disease, and Orphan Drug designations from the United States===Food and Drug Administration and Orphan Drug designation from the European Union===European Commission.