Protagonist Therapeutics announced that rusfertide has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA). This designation is for the treatment of erythrocytosis in patients with polycythemia vera (PV).
The Breakthrough Therapy designation complements rusfertide's existing Orphan Drug and Fast Track designations, which together confer multiple benefits to the development program. This includes more intensive FDA guidance and an expedited review process.
The U.S. New Drug Application (NDA) filing for rusfertide in polycythemia vera remains on track for the fourth quarter of 2025. This designation underscores the significant clinical data supporting rusfertide's potential to address unmet medical needs in PV patients.
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