NovoSeven® reduces bleeding in the brain but does not improve long-term clinical outcomes.
Novo Nordisk released results of a Phase III trial investigating NovoSeven® (recombinant activated factor VII) for the treatment of people suffering from bleeding in the brain, also known as intracerebral hemorrhage, or ICH.
The trial showed that treatment with NovoSeven® significantly reduced intracerebral bleeding compared to placebo treatment. Improvement in clinical outcomes in terms of functional independence and neurological impairment was observed on day 15 after the bleeding, but mortality and severe disability was not improved at the end of the study period (day 90). With regard to safety, study results were in line with the established safety profile of NovoSeven®.
As mortality and severe disability at day 90 was the primary endpoint of the study, Novo Nordisk has decided not to seek regulatory approval for NovoSeven® in ICH.
“These results are disappointing, particularly given the encouraging results we saw in the Phase II trial,” said Lars Rebien Sorensen, president and CEO of Novo Nordisk. “We hoped that NovoSeven® could become a treatment for the people who suffer from ICH and for whom no effective medical treatment exists.”
The Phase III trial in ICH involved 821 patients from 22 countries in a multicentre, randomized, double-blind, placebo-controlled efficacy and safety study.