FDA Approves Mimrylo (Rusfertide) for Polycythemia Vera, Offering New Treatment for Excess Red Blood Cells

The U.S. Food and Drug Administration (FDA) has approved Mimrylo (rusfertide) for the treatment of erythrocytosis in adults with polycythemia vera (PV). This marks the first approval of a hepcidin mimetic, a new class of therapy designed to control excess red blood cell production by limiting iron availability. The approval is based on the Phase 3 VERIFY trial, which demonstrated that 76.9% of patients receiving Mimrylo maintained hematocrit control without requiring phlebotomy, compared to 32.9% on placebo. This offers a new once-weekly subcutaneous option for PV patients who continue to need frequent blood-removal procedures despite standard care.