FDA clears Takeda and Protagonist's rusfertide (Mimrylo) for polycythemia vera, opening potential $2 billion market

The Food and Drug Administration has granted clearance to rusfertide, sold under the brand name Mimrylo, for the treatment of polycythemia vera, a rare blood disorder that causes excess red blood cells.

The approval applies to adults with erythrocytosis and does not require prior use of other therapies such as Jakafi, giving the drug a broader‑than‑expected label.

Analysts point to a list price of $4,200 per vial and project peak annual sales could approach $2 billion, creating a significant revenue opportunity for Takeda.

Mimrylo mimics the liver hormone hepcidin, a mechanism that helps control iron levels and lower red blood cell production, marking a novel approach for this disease.