Novo Nordisk reports Etavopivat met co-primary endpoints in HIBISCUS trial

Novo Nordisk (NVO) announced the topline results from HIBISCUS, a pivotal Phase 3 trial of once-daily oral etavopivat in adults and adolescents with sickle cell disease. The results showed that etavopivat successfully met both co-primary endpoints, demonstrating superior reduction in vaso-occlusive crises and superior improvement in haemoglobin response compared to placebo. In the trial, people treated with etavopivat demonstrated a superior reduction in the annualised rate of VOCs of 27% compared to placebo. The time to first VOC was significantly prolonged with etavopivat, with a median time to first VOC of 38.4 weeks versus 20.9 weeks for placebo. In addition, etavopivat demonstrated a superior increase in the proportion of people achieving a Hb response greater than 1g/dL at week 24 of 48.7% compared to 7.2% with placebo, corresponding to an adjusted rate difference of 41.2%. Further, as an exploratory analysis, etavopivat significantly reduced the risk of blood transfusion. In the trial, etavopivat appeared to be well tolerated, with a topline safety profile in line with previous etavopivat trials.