Mimrylo approval opens first hepcidin-mimicking option in polycythemia vera

FDA · 11 hours ago
Mimrylo approval opens first hepcidin-mimicking option in polycythemia vera
  • Mimrylo is approved for adults whose polycythemia vera remains inadequately controlled with existing therapies and frequent phlebotomies.
  • In the 293-patient VERIFY phase 3 trial, 76.9% of Mimrylo-treated patients required no phlebotomies during the measured period, versus 32.9% of placebo patients.
  • The most common adverse reactions were injection-site reactions and anemia; Takeda Pharmaceuticals America received the approval.

Quotes

Today's approval of Mimrylo offers a new, first-in-class option that has the potential to meaningfully reduce patient burden.Tanya Wroblewski, M.D.

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