FDA approves hepcidin mimetic for PV - Takeaways - MDSpire
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FDA approves hepcidin mimetic for PV

Phase 3 VERIFY results showed a 77% clinical response rate during weeks 20 to 32.

  • By

  • Kathryn Wighton

  • August 31, 2026

  • 3 min

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  • 1

    Rusfertide (MIMRYLO) received FDA approval for treating erythrocytosis in adults with polycythemia vera.

  • 2

    Polycythemia vera is a chronic blood cancer characterized by elevated hematocrit, increasing the risk of thrombotic events.

  • 3

    The phase 3 VERIFY trial showed that 77% of patients on rusfertide plus standard care achieved a clinical response.

  • 4

    Rusfertide is administered weekly via subcutaneous injection and is designed to control hematocrit and reduce phlebotomy needs.

  • 5

    Common adverse reactions to rusfertide include injection-site reactions (56%) and anemia (16%), with warnings for thrombocytosis and embryo-fetal toxicity.

Original Source(s)

FDA approves hepcidin mimetic for PV

  • by Kathryn Wighton

  • August 31, 2026

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