Posted by Michael Wonder on 28 Jun 2021
Catalyst Biosciences receives FDA fast track designation for subcutaneous MarzAA for the treatment of episodic bleeding in factor VII deficiency
28 June 2021 - Catalyst Biosciences today announced the U.S. FDA has granted fast track designation for Marzeptacog alfa (activated), MarzAA, the Company’s subcutaneously administered next-generation engineered coagulation factor VIIa for the treatment of episodic bleeding in subjects with Factor VII deficiency.
Catalyst is currently enrolling patients with factor VIIa deficiency in a Phase 1/2 open-label study. This trial is being conducted in parallel with the ongoing Phase 3 registration trial evaluating MarzAA for the treatment of episodic bleeds in patients with haemophilia A or B with inhibitors.
