Takeda Wins FDA Approval for MIMRYLO in Polycythemia Vera
Takeda won FDA approval for MIMRYLO, a first-in-class hepcidin mimetic for treating erythrocytosis in adults with polycythemia vera and uncontrolled hematocrit. Results from the randomized Phase 3 VERIFY study showed a 76.9% clinical response rate among 293 patients, targeting hematocrit control and potentially reducing risk tied to excessive red blood cell production.