The trial did show that treatment with NovoSeven reduced intracerebral bleeding compared to placebo and there was an improvement in terms of functional independence and neurological impairment.
However, mortality and severe disability was not improved at the end of the study period. As mortality and severe disability was the primary endpoint of the study, Novo Nordisk has decided not to seek regulatory approval for NovoSeven.
“These results are disappointing, particularly given the encouraging results we saw in the phase II trial,” commented Lars Rebien Sorensen, president and CEO of Novo Nordisk.
Novo Nordisk said the results of the phase III trial do not change its expectations for the company’s financial results for 2007.