Why did the FDA approve Takeda’s Mimrylo for polycythemia vera patients?

The FDA approved Takeda’s Mimrylo (rusfertide) on August 28, 2026 for adults with polycythemia vera who still need frequent phlebotomies despite standard care. In the phase 3 VERIFY trial, 76.9% of patients on Mimrylo avoided phlebotomy during 32 weeks versus 32.9% on placebo, supporting its role as the first hepcidin-mimicking treatment for the disease.