EQS-News: Biotest successfully meets primary endpoint in phase III trial with Fibrinogen concentrate
Biotest announced today that the AdFIrst (Adjusted FIbrinogen replacement strategy) phase III trial met its primary endpoint, demonstrating that Fibrinogen concentrate is non-inferior to standard of care in reducing intraoperative blood loss in patients with acquired fibrinogen deficiency undergoing planned major spinal or abdominal surgery.
- Biotest announced today that the AdFIrst (Adjusted FIbrinogen replacement strategy) phase III trial met its primary endpoint, demonstrating that Fibrinogen concentrate is non-inferior to standard of care in reducing intraoperative blood loss in patients with acquired fibrinogen deficiency undergoing planned major spinal or abdominal surgery.
- The AdFIrst trial was a prospective, randomised, active-controlled, multicentre phase III trial involving 222 patients undergoing elective spine or abdominal surgery.
- This would be the first fibrinogen concentrate approved for an acquired fibrinogen deficiency indication in the US.
- Compared with congenital fibrinogen deficiency, where efficacy has been demonstrated in an earlier trial, the market size for the treatment of acquired fibrinogen deficiency is many times larger.