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Takeda wins FDA approval for PV drug Mimrylo (rusfertide)

28. Aug 2026

(AWP Alliance News) - Takeda won US FDA clearance for MIMRYLO (rusfertide) to treat erythrocytosis in adults with polycythemia vera. The first-in-class hepcidin mimetic is designed to control hematocrit below 45% by regulating iron distribution and red blood cell overproduction.

Approval was backed by the Phase 3 VERIFY trial in 293 patients, which showed improved hematocrit control, fewer phlebotomies, and reduced fatigue versus placebo on standard care. Takeda maintained its consolidated forecast for the fiscal year ending March 31, 2027.

https://www.businesswire.com/news/home/20260824773270/en/

Disclaimer: This news brief was created using generative artificial intelligence. Takeda Pharmaceutical Co. Ltd. published the original content used to generate this news brief via Business Wire on August 28, 2026, and is solely responsible for the information contained therein.

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