Catalyst Biosciences Receives FDA Fast Track Designation for Subcutaneous MarzAA for the Treatment of Episodic Bleeding in Factor VII Deficiency
Catalyst Biosciences, Inc. recently announced the US FDA has granted Fast Track Designation for Marzeptacog alfa (activated), MarzAA, the company’s subcutaneously (SQ) administered next-generation engineered coagulation Factor VIIa (FVIIa) for the treatment of episodic bleeding in subjects with Factor VII deficiency. Catalyst is currently enrolling patients with FVII 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 Hemophilia A or B with inhibitors.
Fast Track is an FDA process designed to facilitate and expedite the development and review of drug candidates that have demonstrated the potential to address an unmet medical need in treating serious diseases or conditions. A drug candidate with Fast Track designation is eligible for greater access to the FDA as well as a priority review and rolling review of the marketing application.
“Receiving a second Fast Track designation is another important milestone in our MarzAA development program. We look forward to our continued collaboration with the FDA to bring a safe and effective treatment to patients with Factor VII deficiency, Hemophilia A or B with inhibitors, Glanzmann Thrombasthenia and other severe bleeding disorders.” said Nassim Usman, PhD, President and Chief Executive Officer of Catalyst. “MarzAA is the only subcutaneously administered bypassing agent under development for the episodic treatment of bleeding events and has the potential to significantly improve the lives of patients with several inherited or acquired bleeding disorders.”
FDA granted Fast Track Designation for MarzAA for the SQ treatment and control of episodic bleeding in subjects with Hemophilia A or B with inhibitors in December 2020.
Catalyst is a research and clinical development biopharmaceutical company focused on addressing unmet medical needs in rare disorders of the complement and coagulation systems. Our protease engineering platform has generated two late-stage clinical programs, including MarzAA, an SQ-administered next-generation engineered rFVIIa for the episodic treatment of bleeding in subjects with rare bleeding disorders. Our complement pipeline includes a preclinical C3-degrader program licensed to Biogen for dry age-related macular degeneration, an improved complement factor I protease for SQ replacement therapy in patients with CFI deficiency, and C4b-degraders designed to target disorders of the classical complement pathway, as well as other complement programs in discovery.
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