The US Food and Drug Administration has approved has approved rusfertide (Mimrylo) as a first-in-class hepcidin mimetic to treat erythrocytosis in adults with polycythemia vera.
The medication regulates iron distribution to help patients maintain target hematocrit levels and reduce the physical burden of frequent therapeutic blood draws, according to Takeda, the manufacturer of the drug.
In a press release, Takeda stated approval was supported by results from the global randomized phase 3 VERIFY trial involving 293 patients, which showed that patients receiving rusfertide demonstrated a higher clinical response rate, including maintained hematocrit control and reduced phlebotomy requirements, compared to placebo alongside standard care.
“For patients living with PV, uncontrolled hematocrit can have serious consequences …The strength and consistency of the VERIFY data give me real confidence in its potential to advance how we treat PV in everyday practice and to maintain hematocrit control,” said Andrew T. Kuykendall, MD, VERIFY lead investigator and associate member in the department of hematology at Moffitt Cancer Center in Tampa, Florida.
Watch Dr. Kuykendall discuss the VERIFY trial and rusfertide’s impact on PV treatment.
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