Takeda and Protagonist Therapeutics Receive U.S. FDA Approval for MIMRYLO (rusfertide) to Treat Polycythemia Vera

Takeda Pharmaceuticals and Protagonist Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved MIMRYLO (rusfertide) for the treatment of erythrocytosis in adults with polycythemia vera (PV), a rare blood cancer. MIMRYLO is a first-in-class hepcidin mimetic peptide designed to regulate iron distribution and red blood cell overproduction. This approval triggers $275 million in milestone payments to Protagonist, including a $200 million opt-out fee and a $75 million approval milestone, with potential for up to an additional $875 million in future milestones and tiered royalties.