TakedaandProtagonistAnnounceSubmissionofNewDrugApplication(NDA)forRusfertideforTreatmentofPolycythemiaVera(PV)
===2026/1/6 14:02:32===
发布时间:2026-01-06 13:47
Rusfertide Is a First-in-Class Investigational Hepcidin Mimetic That Targets Red Blood Cell Overproduction (Erythrocytosis) in Polycythemia Vera
NDA Includes 52-Week Data from Phase 3 VERIFY Study, Which Met the Primary and All Four Key Secondary Endpoints, Showing Rusfertide Provided Durable and Sustained Hematocrit Control and Improved Pre-Specified Patient Reported Outcome Measures
Data Underscore the Potential to Shift the Treatment Paradigm for PV Patients to Reduce the Burden of Frequent Phlebotomies and Meaningfully Improve Hematocrit Control
OSAKA, Japan & CAMBRIDGE, Mass. & NEWARK, Calif.--(BUSINESS WIRE)--Takeda (TSE:4502/NYSE:TAK) and Protagonist Therapeutics (Nasdaq: PTGX) (“Protagonist”) announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of rusfertide for the treatment of adults with polycythemia vera (PV). Rusfertide is an investigati
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