Protagonist Therapeutics Announces U.S. FDA Approval of Hepcidin Mimetic Peptide MIMRYLO(TM) (rusfertide) for Polycythemia Vera

Protagonist Therapeutics said Takeda received U.S. FDA approval for MIMRYLO (rusfertide) to treat erythrocytosis in adults with polycythemia vera (PV). The company calls it the first and only hepcidin mimetic peptide therapy approved for PV, delivered subcutaneously. Protagonist notes the label reflects control of hematocrit and improved fatigue measured by PROMIS Fatigue Short Form 8a. Approval was supported by Phase 3 VERIFY results in which 76.9% of patients achieved a response during weeks 20–32. The announcement also cites $275M in milestones tied to FDA approval, 14%–29% royalties, and up to an additional $875M in potential future milestones.