Denmark’s Novo Nordisk says that it has decided not to seek regulatory approval for its drug NovoSeven to treat bleeding in the brain, on the back of disappointing late-stage data.
Novo will not apply for regulatory approval for NovoSeven (recombinant Factor VIIa) to treat intracerebral haemorrhage (ICH), after mortality and severe disability had not improved after a 90-day study period. A Phase III stroke trial showed that its NovoSeven reduced bleeding in the brain, but did not achieve long-term improvement.
The trial involved 821 patients from 22 countries in a multi-centre, randomised, double-blind, placebo-controlled efficacy and safety study and people suffering from spontaneous ICH confirmed by a scan were randomised to receive either NovoSeven or placebo within four hours of symptom onset, in addition to conventional treatment.
Lars Rebien Sorensen, Novo’s chief executive, said: "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."
The markets have reacted badly to the news and Novo’s shares have fallen almost 8% in early morning trading on the Copenhagen stock exchange.