2 December 2020 - Catalyst Biosciences today announced the U.S. FDA has granted fast track designation for marzeptacog alfa (activated) – or MarzAA, the Company’s subcutaneously administered next-generation engineered coagulation factor VIIa (FVIIa) for the treatment of episodic bleeding in subjects with haemophilia A or B with inhibitors that will enter a pivotal Phase 3 CRIMSON 1 trial this month.
The Phase 3 CRIMSON 1 trial is an open-label, global, multi-centre, randomised, cross-over study, designed to evaluate the safety and efficacy of MarzAA for on-demand treatment of spontaneous or traumatic bleeding episodes, in adolescents and adults with congenital haemophilia A or B with inhibitors, compared to the standard of care.