TakedaandProtagonistAnnounceSubmissionofNewDrugApplication(NDA)forRusfertideforTreatmentofPolycythemiaVera(PV)
===2026/1/6 14:02:32===
t and all four key secondary endpoints, as well as the Phase 2 REVIVE study (NCT04057040). In the VERIFY study, patients receiving rusfertide plus standard of care therapy demonstrated a substantially higher response rate compared to placebo plus standard of care, including durable hematocrit control, a reduction in phlebotomy requirements and improvement in pre-specified patient reported outcome (PRO) endpoints.
Rusfertide has received Breakthrough Therapy Designation, a regulatory milestone recognizing the potential of rusfertide to offer a substantial improvement over available therapies, as well as Orphan Drug Designation and Fast Track Designation from the U.S. FDA.
“Rusfertide has the potential to redefine the treatment paradigm for PV by offering patients a novel, first-in-class erythrocytosis-specific therapy that significantly reduces or eliminates the need for frequent phlebotomy,” said Dinesh V. Patel, Ph.D., Protagonist President and CEO. &ld
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