FDA Approval · August 28, 2026 · Polycythemia Vera
FDA Approves Rusfertide (Mimrylo) for Polycythemia Vera — First Hepcidin Mimetic in Clinical Practice
Takeda's rusfertide becomes the first synthetic hepcidin mimetic approved by any regulatory agency. The VERIFY trial (N=293) showed 76.9% clinical response versus 32.9% with placebo, phlebotomy requirements dropped from 1.8 to 0.5 per 12 weeks, and HCT <45% sustained in 62.6% vs 14.4%. The mechanism — targeting the iron-sensing pathway rather than JAK2 — represents an entirely new approach to PV management.
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