Concluding that a late-stage trial of its experimental therapy to prevent bleeding in trauma patients was headed to a likely failure, Novo Nordisk discontinued the study of NovoSeven. "Due to an observed lower mortality than anticipated in the overall study group (around 10 percent in the Phase III trial in total compared to more than 25 percent in the Phase II trial), a futility analysis was conducted to assess the likelihood of reaching a successful outcome on the primary endpoint. The analysis predicted a low likelihood of obtaining a positive trial outcome with the planned study population, and as a consequence, Novo Nordisk has decided to discontinue the trial," the company announced.
"It is regrettable that this trial is coming to an end," said Mads Krogsgaard Thomsen, executive vice president and CSO. "It has, however, already now provided a lot of important data on the treatment of severely injured patients. We will share these findings with the medical community as soon as the full clinical analysis has been completed."
- check out Novo's release