Phase 3 Trial of Gene Therapy SB-525 for Hemophilia A on FDA Hold

Phase 3 Trial of Gene Therapy SB-525 for Hemophilia A on FDA Hold

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Phase 3 Trial of Gene Therapy SB-525 for Hemophilia A on FDA Hold

The U.S. Food and Drug Administration (FDA) has placed a clinical hold on the Phase 3 trial evaluating SB-525 (giroctocogene fitelparvovec), an investigational gene therapy for hemophilia A. This pause in study recruitment and dosing was taken to give the agency time to review changes to the AFFINE trial’s protocol after unusually high factor levels were reported in some treated patients. SB-525 is designed to deliver a healthy copy of the gene that encodes factor…

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