Novo Nordisk to seek oral sickle cell therapy approval after Phase III victory

APhase III trial of Novo Nordisk’s once-daily tablet has met both co-primary endpoints, reducing vaso-occlusive crises (VOC) and increasing haemoglobin (Hb) response in patients with sickle cell disease (SCD).

In the pivotal HIBISCUS trial (NCT04624659), the etavopivat arm demonstrated a 27% reduction in the annualised rate of VOCs compared to placebo, with time to first VOC being significantly prolonged with etavopivat at 38.4 weeks compared to 20.9 weeks for placebo.

Etavopivat also demonstrated a 48.7% increase in the proportion of people achieving a Hb response greater than 1g/dL at week 24 compared to 7.2% with placebo.