FDA Approves First-in-Class Hepcidin Mimetic Peptide MIMRYLO for Polycythemia Vera

The U.S. Food and Drug Administration (FDA) has approved MIMRYLO (rusfertide), a subcutaneously delivered hepcidin mimetic peptide, for the treatment of erythrocytosis in adults with polycythemia vera (PV). This marks the first and only hepcidin mimetic approved for PV, a rare blood cancer characterized by excessive red blood cell production. The approval is supported by Phase 3 VERIFY results, showing 76.9% of patients achieved a response during weeks 20-32, and the drug also demonstrated improvement in fatigue.