FDA approves first-of-its-kind Mimrylo drug for rare blood cancer

  • FDA approves Takeda and Protagonist’s rusfertide treatment for polycythemia vera.
  • 90,000 Americans are affected by the rare blood cancer.
  • Mimrylo will be available within 48 hours of FDA approval, Takeda says.

The FDA (U.S. medicines regulator) has approved rusfertide, branded as Mimrylo, from Takeda Pharmaceutical and Protagonist Therapeutics to treat polycythemia vera, a rare, slow-growing blood cancer. The disease causes bone marrow to produce excess red blood cells, thickening the blood and raising the risk of life-threatening clots, strokes and heart attacks. The first-of-its-kind treatment offers patients a less-invasive alternative to frequent bloodletting procedures. Takeda said Mimrylo will be available within 48 hours of FDA approval, while declining to disclose its launch price. Teresa Bitetti, president of Takeda’s global oncology business unit, said the company would price the drug fairly while ensuring patient access. Takeda projects peak global sales of $1 billion to $2 billion.

The information on this website is generated using AI and we cannot guarantee its accuracy. Please use it as reference information only.