NEJM Publishes Promising Study of NovoSeven Coagulation Factor VIIa

Novo Nordisk has announced the results of a recently completed clinical trial of NovoSeven Coagulation Factor VIIa (recombinant) in patients with acute intracerebral hemorrhage (ICH) as published in The New England Journal of Medicine (NEJM).

The NEJM article, "Recombinant Activated Factor VII for Acute Intracerebral Hemorrhage," presents the results of the largest clinical trial ever conducted with a pharmacologic agent for the treatment of ICH. The study found a reduction in hematoma growth (bleeding in the brain), decreased mortality, and improvement in neurological and clinical outcomes in patients treated with NovoSeven compared to placebo.

The trial results showed that treatment of ICH with recombinant activated Factor VII (rFVIIa) within four hours of symptom onset reduced mortality and improved three-month clinical outcome, along with the reduction in hematoma growth, despite a greater frequency of thromboembolic events. The trial included 399 patients, all diagnosed by computed tomography imaging within three hours of ICH onset. Patients were randomly assigned to receive placebo, 40-, 80- or 160-µg/kg doses of rFVIIa within one hour of the baseline scan. The primary endpoint of the study was to determine if rFVIIa could reduce hematoma growth after ICH. The primary outcome measure was the percent change in ICH volume at 24 hours. Clinical outcomes were assessed at 90 days.