Takeda Pharmaceutical Co. Ltd. and Protagonist Therapeutics announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for rusfertide, an investigational treatment for adults with polycythemia vera (PV). The submission is based on positive results from the VERIFY Phase 3 and REVIVE Phase 2 studies, which demonstrated rusfertide's effectiveness in controlling hematocrit levels, reducing the need for phlebotomy, and improving patient-reported outcomes. Rusfertide has received Breakthrough Therapy, Orphan Drug, and Fast Track designations from the FDA, recognizing its potential to address critical needs in PV treatment. Under their collaboration agreement, Protagonist Therapeutics may receive significant milestone and royalty payments depending on future development and commercialization decisions.

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