Takeda gains approval of rusfertide for polycythemia vera
The approval is backed by Phase 3 VERIFY data showing 76.9% response rates and lower phlebotomy use compared with placebo.
- On Friday, August 28, 2026, the U.S. Food and Drug Administration approved Takeda Pharmaceutical Company Limited's MIMRYLO for erythrocytosis in adults with polycythemia vera .
- Polycythemia vera affects approximately 90,000 people in the U.S., where 78% of patients experience uncontrolled hematocrit levels despite standard care including phlebotomy and cytoreductive therapies.
- In the Phase 3 VERIFY study, 76.9% of patients receiving MIMRYLO achieved clinical response during weeks 20-32, compared with 32.9% receiving placebo.
- The FDA approval triggers $275 million in payments to Protagonist Therapeutics, with potential for an additional $875 million in milestones and 14% to 29% tiered royalties.
- Protagonist Therapeutics will host an investor call on Monday, August 31, 2026, at 8:30 am ET to discuss this first-in-class hepcidin mimetic therapy.
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Weatherford Democrat
Protagonist Therapeutics Announces U.S. FDA Approval of Hepcidin Mimetic Peptide MIMRYLO(TM) (rusfertide) for Polycythemia Vera
MIMRYLO™ is the First and Only Hepcidin Mimetic Peptide Therapy Approved for the Treatment of Erythrocytosis in Adults with Polycythemia Vera, Offering a Novel Mechanism to Maintain Hematocrit Control, Meaningfully Reduce Phlebotomy Burden, and Improve Fatigue
Financial Post
India ShortsTakeda Receives U.S. FDA Approval of MIMRYLO™ (rusfertide), Marking a Potential Shift in the Treatment Paradigm for Polycythemia Vera
OSAKA, Japan & CAMBRIDGE, Mass. -- Takeda ( TSE:4502/NYSE:TAK) announced U.S. Food and Drug Administration (FDA) approval of the New Drug Application (NDA)* for MIMRYLO™ (rusfertide) for the treatment of erythrocytosis in adults with polycythemia vera (PV), a blood cancer.
Takeda Receives U.S. FDA Approval of MIMRYLO™ (rusfertide), Marking a Potential Shift in the Treatment Paradigm for Polycythemia Vera – Novumpr
MIMRYLO, a First-in-Class Medicine with a Unique Mechanism of Action, is Approved for the Treatment of Erythrocytosis in Adults with Polycythemia Vera (PV) MIMRYLO Has Been Shown to Maintain Hematocrit Control, the Primary Treatment Goal in PV, as Well as Reduce Phlebotomy Burden and Improve Fatigue Approval Supported by Phase 3 VERIFY Results Showing 76.9% […]
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