Takeda receives US FDA approval of Mimrylo

29 August 2026

Japan’s largest drugmaker Takeda (TYO: 4502) announced that the US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Mimrylo (rusfertide) for the treatment of erythrocytosis in adults with polycythemia vera (PV), a blood cancer.

Mimrylo is a first-in-class hepcidin mimetic designed to regulate iron distribution in the body and red blood cell overproduction to control hematocrit levels, which is the ratio of red blood cells to the total amount of blood in the body. Maintaining controlled hematocrit levels below 45% is the primary treatment goal in PV.

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