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Takeda and Protagonist Announce U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Rusfertide as a Potential First-in-Class Therapy for Polycythemia Vera
OSAKA, Japan & CAMBRIDGE, Mass. & NEWARK, Calif., March 02, 2026--Takeda (TSE:4502/NYSE:TAK) and Protagonist Therapeutics, Inc. ("Protagonist") (NASDAQ:PTGX) today announced that the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) and granted Priority Review for rusfertide. Rusfertide is an investigational, first-in-class hepcidin mimetic peptide therapeutic for the treatment of adults with polycythemia vera (PV). The FDA has set a Prescription Drug User Fee Act (
About this update from Takeda Pharmaceutical Co. Ltd.
[{"type":"list","items":[{"val":[{"type":"text","content":"Rusfertide Demonstrated Significant Improvements in Hematocrit Control, Phlebotomy Reduction and Patient Reported Outcomes for Patients with Polycythemia Vera in a Pivotal Study","length":177,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Submission Primarily Based on Phase 3 VERIFY Study, in Which Rusfertide Plus Standard of Care More Than Doubled Clinical Response Rates, as Well as Four-Year Efficacy and Safety Data from Phase 2 REVIVE/THRIVE Studies","length":217,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Prescription Drug User Fee Act (PDUFA) Target Action Date is in the Third Quarter of this Calendar Year","length":103,"tagName":"p","attribs":{}}]}],"tagName":"ul","bulletedList":true,"length":497,"olType":false},{"type":"text","content":"OSAKA, Japan & CAMBRIDGE, Mass. & NEWARK, Calif., March 02, 2026--(BUSINESS WIRE)--Takeda (TSE:4502/NYSE:TAK) and Protagonist Therapeutics, Inc. ("Protagonist") (NASDAQ:PTGX) today announced that the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) and granted Priority Review for rusfertide. Rusfertide is an investigational, first-in-class hepcidin mimetic peptide therapeutic for the treatment of adults with polycythemia vera (PV). The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date in the third quarter of this calendar year. In addition to Priority Review, rusfertide has received Breakthrough Therapy designation, Orphan Drug designation and Fast Track designation from the U.S. FDA.","length":755,"tagName":"p"},{"type":"text","content":"PV is characterized by the overproduction of red blood cells (erythrocytosis), which increases blood viscosity, or thickness, and can result in life threatening thrombotic events. Hematocrit is the ratio of red blood cells to the total amount of blood in the body. Achieving and maintaining controlled hematocrit levels of <45% is the primary treatment goal in PV to prevent thrombotic events and alleviate burdensome symptoms.","length":430,"tagName":"p"},{"type":"text","content":""There is an urgent need for innovative treatment options in polycythemia vera, where patients currently face limited therapeutic choices to control their hematocrit and significant symptom burden," said Andy Plump, M.D., Ph.D., president o...