Mimrylo snags FDA approval for first-of-its-kind polycythemia vera treatment

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August 31, 2026↗ source

The FDA approved rusfertide (Mimrylo, from Protagonist Therapeutics and Takeda) for erythrocytosis in adults with polycythemia vera who haven't achieved adequate control on other treatments. The approval rests on the phase 3 VERIFY trial, where 76.9% of rusfertide patients needed no phlebotomy between weeks 20 and 32 versus 32.9% on placebo. Dosing is weekly subcutaneous injection starting at 19 mg. Rusfertide is a hepcidin mimetic — the connection to the iron-regulatory peptide named in the companion research review; this article itself focuses on clinical results, dosing, and safety warnings.

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