FDA Approves Mimrylo (rusfertide) as First-in-Class Treatment 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), a rare blood disorder. This marks the first approved treatment for PV that mimics hepcidin, a hormone that naturally regulates iron in the body, aiming to control hematocrit levels and reduce red blood cell overproduction. The approval is based on Phase 3 VERIFY trial results, which showed that 76.9% of patients on Mimrylo did not require phlebotomies during a 32-week period, compared to 32.9% on placebo.