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Aug 28, 2026

FDA approves Mimrylo, first-of-its-kind drug for polycythemia vera

The U.S. Food and Drug Administration approved Mimrylo (rusfertide), developed by Takeda Pharmaceutical and Protagonist Therapeutics, as the first drug of its kind to treat polycythemia vera, a rare blood disorder that causes overproduction of red blood cells.

Aug 28, 2026·3 sources
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Top claims

  • ▪Takeda Pharmaceutical aims to launch zasocitinib, an oral TYK2 inhibitor for psoriasis, in the United States in the first half of 2027 to help offset generic erosion.
  • ▪On August 28, 2026, the U.S. Food and Drug Administration approved Mimrylo (rusfertide) to treat adults with polycythemia vera, a rare blood cancer.
  • ▪Takeda Pharmaceutical plans to make Mimrylo available to patients within 48 hours of FDA approval, projecting peak global sales for the drug in the range of $1 billion to $2 billion.

Subtopics

Rare diseases

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