Novo Nordisk has given up on plans to seek regulatory approval for NovoSeven as a therapy for bleeding in the brain after a late-stage study demonstrated reduced bleeding but no long term benefits. By day 15 of a pivotal study patients taking NovoSeven demonstrated significantly reduced bleeding compared to a placebo. But there was no improvement after 90 days, the study's primary endpoint.
"These results are disappointing, particularly given the encouraging results we saw in the Phase II trial. We hoped that NovoSeven could become a treatment for the people who suffer from ICH, and for whom no effective medical treatment exists," said Lars Rebien Sørensen, president and CEO of Novo Nordisk.
- see Novo Nordisk's release on NovoSeven
- read the AFX report