Takeda’s Rusfertide Gains FDA Priority Review with Q3 2026 PDUFA Date
FDA has granted Priority Review to Takeda’s rusfertide NDA with a PDUFA action date in Q3 2026 after phase 3 VERIFY data showed more than double response rates and sustained hematocrit control below 45%. Takeda will lead global regulatory filings while Protagonist retains a US profit-share option on rusfertide commercialization.
1. FDA Grants Priority Review
The US FDA accepted Takeda’s NDA for rusfertide and granted Priority Review, assigning a PDUFA action date in Q3 2026 for this investigational hepcidin mimetic in polycythemia vera.
2. Clinical Trial Results
Phase 3 VERIFY data showed rusfertide more than doubled response rates over standard care and maintained hematocrit below 45%, while Phase 2 REVIVE and THRIVE trials reported reduced phlebotomy needs and improved fatigue symptoms.
3. Collaboration Terms
Under the 2024 collaboration, Takeda manages global regulatory strategy and future filings, and Protagonist retains an option to co-commercialize rusfertide in the US under a profit-sharing agreement.