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FDA approves Takeda's MIMRYLO for polycythemia vera; 76.9% of patients achieved clinical response in Phase 3 study
TAKTakeda Pharmaceutical Co Ltd
Takeda Pharmaceutical Company Limited received U.S. FDA approval for MIMRYLO (rusfertide), a first-in-class hepcidin mimetic indicated for the treatment of erythrocytosis in adults with polycythemia vera. The approval is supported by Phase 3 VERIFY study results, which demonstrated that 76.9% of patients achieved clinical response during weeks 20-32, maintaining hematocrit control and reducing phlebotomy burden. Takeda stated this approval does not change its consolidated financial forecast for the fiscal year ending March 31, 2027. The company operates in the pharmaceutical industry, focusing on discovering and delivering life-transforming treatments across various therapeutic areas including oncology and rare diseases.