FDA has cleared Takeda’s rusfertide (marketed as Mimrylo) for polycythemia vera, expanding the label for a rare blood cancer treatment originally developed by Protagonist Therapeutics. The decision provides Takeda a new annual revenue opportunity that some analysts project could reach $2 billion or more, depending on uptake and payer coverage. The weekly-injection hepcidin mimetic is designed to address the excess red blood cell production that drives patient risk of thrombotic events. With the broader-than-expected approval, Takeda now has additional flexibility in positioning the drug within PV treatment pathways. The approval also underscores the agency’s continued willingness to advance hepcidin-pathway therapeutics for rare hematologic indications where clinical need remains high.