Novo Nordisk’s haemophilia treatment, NovoSeven (recombinant Factor VIIa), helps reduce bleeding limit brain damage in patients with intracerebral haemorrhage – the deadliest and most disabling type of stroke, according to trial data published in the current edition of the New England Journal of Medicine.
The trial included 399 patients, all diagnosed by a CT scan within three hours of ICH onset, who received either placebo, or varying doses of NovoSeven within one hour of the scan. There was a statistically significant reduction in haematoma growth amongst the NovoSeven groups versus those given placebo. In addition, 69% of placebo-treated patients died or were severely disabled at 90 days after dosing, compared to between 49% and 55% of patients receiving NovoSeven, depending on the dose. This led to a 16% absolute reduction in the risk of death or severe disability at three months. Mortality was 38% lower in the combined NovoSeven-treated groups compared to placebo.
Overall, the data suggest indicate that early administration of NovoSeven to patients with ICH may limit haematoma growth, reduce mortality and improve neurological and clinical outcomes without significantly raising the risk of fatal or disabling thromboembolic complications.
The firm notes that the unmet medical need for a treatment of ICH is recognised by neurologists around the world as a serious medical emergency. The volume of bleeding into the brain is an important predictor of neurological and clinical outcomes after 30 days and it has been well documented that such bleeding continues over the early hours following symptom onset.
