FDA Approves Mimrylo, First-in-Class Hepcidin Mimetic, for Polycythemia Vera

The U.S. Food and Drug Administration (FDA) has approved Mimrylo (rusfertide) for the treatment of erythrocytosis in adults with polycythemia vera (PV). Mimrylo is the first approved hepcidin mimetic, working by limiting iron availability for red blood cell production to control hematocrit. The approval was supported by the Phase 3 VERIFY trial, which showed 76.9% of patients on Mimrylo maintained hematocrit control without frequent phlebotomies, compared to 32.9% on placebo.