Novo Nordisk nach Split WKN: A3EU6F ISIN: DK0062498333 Kürzel: NOV Forum: Aktien User: Coronaprofiteur
$NVO $NOVO Novo Nordisk has announced the topline results from HIBISCUS, a pivotal phase 3 trial of once-daily oral etavopivat in adults and adolescents with sickle cell disease (SCD). The results showed that etavopivat successfully met both co-primary endpoints, demonstrating superior reduction in vaso-occlusive crises (VOCs) and superior improvement in haemoglobin (Hb) response compared to placebo. Etavopivat is an oral, once-daily, pyruvate kinase-R (PKR) activator being developed to treat SCD, a seriously debilitating, life-threatening and life-shortening disease that impacts around 8 million people worldwide. The HIBISCUS trial was a randomised, double-blinded, 52-week efficacy and safety trial investigating etavopivat 400 mg versus placebo in 385 people aged 12 years or older with SCD. Participants were allowed to receive standard of care treatment throughout the trial. 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%1. 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. Novo Nordisk plans to submit for the first regulatory approval of etavopivat in the second half of 2026. The detailed results from the HIBISCUS phase 3 trial will be presented at a scientific conference in 2026.
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