NovoSeven misses Ph III trial primary endpoint
The world's largest insulin maker, Novo Nordisk, has reported disappointing results from a Phase III trial of its recombinant coagulation factor, NovoSeven, in the treatment of intracranial hemorrhage (ICH) and the firm has decided not to seek approval for this indication.
According to the Danish firm, while the agent demonstrated a significant reduction in intracerebral bleeding versus placebo, as well as an improvement in neurological impairment on day 15 after bleeding, it missed the primary endpoint of improved mortality and severe disability at day 90.
Many analysts see NovoSeven as key to the firm's plans to expand beyond its leading position in diabetes and the market reacted negatively to the results. On the day of the news, February 26, shares in Novo Nordisk fell 5.4% to 485.5 Danish kroner.
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