Takeda Pharmaceutical (TAK) said late Friday the US Food and Drug Administration approved rusfertide for the treatment of erythrocytosis in adults with polycythemia vera, a rare type of blood cancer.

The approval is supported by data from a phase 3 study that showed rusfertide plus standard of care demonstrated higher response rate, including hematocrit control, reduced phlebotomy and improved fatigue compared with placebo plus standard of care, the company said.

The treatment was generally well tolerated through 52 weeks, with injection-site reactions and anemia among the most common treatment-emergent adverse events, Takeda said.

The approval does not change Takeda's consolidated financial guidance for fiscal 2026, it said.