FDA grants Breakthrough Therapy status to Rusfertide for treating a blood disorder linked to polycythemia vera.

The FDA has granted Breakthrough Therapy Designation to Rusfertide for treating erythrocytosis in patients with polycythemia vera (PV). This designation, supported by positive Phase 3 study results, aims to expedite the drug's development and review, offering potential benefits over current treatments for this blood disorder. Rusfertide, co-developed with Takeda Pharmaceuticals, is on track for a New Drug Application submission by the end of 2025.