Product/Regulation
FDA approves Mimrylo, the first hepcidin mimetic for adult polycythemia vera
The Food and Drug Administration approved Mimrylo (rusfertide) on August 28, 2026, for adults with polycythemia vera. In the VERIFY trial of 293 adults, 76.9% on Mimrylo required no phlebotomies during the 32-week period, compared with 32.9% on placebo. Takeda Pharmaceuticals America holds the NDA. Takeda said the approval does not change its forecast for the fiscal year ending March 31, 2027.
