US FDA Approves MIMRYLO (rusfertide) for Polycythemia Vera

The U.S. Food and Drug Administration (FDA) has approved Protagonist Therapeutics' hepcidin mimetic peptide MIMRYLO (rusfertide) for the treatment of polycythemia vera. This approval introduces a new therapeutic approach that directly targets red blood cell overproduction by mimicking hepcidin, the body's natural iron regulator. Clinical data from the Phase 3 VERIFY study demonstrated that 76.9% of patients receiving MIMRYLO achieved a clinical response, alongside improvements in fatigue.