FDA Grants Priority Review to Rusfertide for Polycythemia Vera

Key claim: The FDA accepted the NDA for rusfertide and granted priority review for adults with polycythemia vera, with a decision expected in Q3 of this year.

Abstract

The FDA accepted the new drug application for rusfertide (PTG-300) and granted it priority review for the treatment of adults with polycythemia vera (PV). Rusfertide is an investigational, first-in-class hepcidin mimetic peptide designed to help control elevated red blood cell levels in PV. A regulatory decision is expected in the third quarter of this year.

Why this matters

The FDA accepted the NDA for rusfertide and granted priority review for adults with polycythemia vera, with a decision expected in Q3 of this year.

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