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Takeda and Protagonist Announce Submission of New Drug Application (NDA) for Rusfertide for Treatment of Polycythemia Vera (PV)
Rusfertide Is a First-in-Class Investigational Hepcidin Mimetic That Targets Red Blood Cell Overproduction (Erythrocytosis) in Polycythemia Vera NDA Includes
About this update from Protagonist Therapeutics, Inc.
[{"type":"text","content":"\n\nRusfertide Is a First-in-Class Investigational Hepcidin Mimetic That Targets Red Blood Cell Overproduction (Erythrocytosis) in Polycythemia Vera\n\n\n\n\n\nNDA 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\n\n\n\n\n\nData Underscore the Potential to Shift the Treatment Paradigm for PV Patients to Reduce the Burden of Frequent Phlebotomies and Meaningfully Improve Hematocrit Control\n\n\n\n OSAKA, Japan & CAMBRIDGE, Mass. & NEWARK, Calif.--(BUSINESS WIRE)--\nTakeda (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 investigational first-in-class subcutaneously administered hepcidin mimetic peptide designed to regulate iron homeostasis and red blood cell production to control hematocrit levels in patients with PV.\n\n\n“This is an important milestone toward our goal of addressing critical gaps that patients living with polycythemia vera face today,” said Teresa Bitetti, President, Global Oncology Business Unit, Takeda. “The comprehensive VERIFY study data underscore rusfertide’s strong clinical profile and potential to provide sustained hematocrit control while reducing phlebotomy and symptom burden. Our collaboration with Protagonist exemplifies how partnerships can advance innovative science, with a focus on making a meaningful difference for patients.”\n\n\nThis NDA submission follows the positive 32-week primary analysis and 52-week results from the Phase 3 global randomized, placebo-controlled VERIFY study (NCT05210790), in which rusfertide met the primary endpoint 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.\n\n\nRusfertide has receive...