Takeda, Protagonist announce FDA acceptance of rusfertide new drug application

Takeda (TAK) and Protagonist Therapeutics (PTGX) announced that the FDA accepted the new drug application and granted priority review for rusfertide. Rusfertide is an investigational hepcidin mimetic peptide therapeutic for the treatment of adults with polycythemia vera. The FDA has set a Prescription Drug User Fee Act goal date in the third quarter of this calendar year. In addition to priority review, rusfertide has received breakthrough therapy designation, orphan drug designation and fast track designation from the FDA.