FDA Approves MIMRYLO (rusfertide) for Polycythemia Vera, a First-in-Class Hepcidin Mimetic Peptide Therapy

The U.S. Food and Drug Administration (FDA) has approved MIMRYLO (rusfertide), a hepcidin mimetic peptide, for the treatment of erythrocytosis in adults with polycythemia vera (PV). This marks the first and only hepcidin mimetic therapy approved for PV, offering a novel mechanism to control hematocrit levels, reduce phlebotomy burden, and improve fatigue. The approval was supported by Phase 3 VERIFY results, which showed 76.9% of patients achieved a response during weeks 20-32.