Takeda and Protagonist Jointly Announce Rusfertide Granted FDA Priority Review,Set to Become the First-in-Class Therapy for Polycythemia Vera
NewTimeSpace News:On March 2, 2026, Takeda and Protagonist issued a joint announcement disclosing that the FDA has accepted the NDA for Rusfertide and awarded it Priority Review status. In addition, Rusfertide had previously been granted Breakthrough Therapy Designation, Orphan Drug Designation and Fast Track Designation by the FDA.
Rusfertide is an investigational first-in-class hepcidin mimetic peptide therapy. By mimicking the action of endogenous hepcidin, it regulates iron homeostasis and erythropoiesis, aiming to reduce excessive red blood cell production in patients with polycythemia vera and help them maintain controlled hematocrit levels.
The announcement specified that the NDA is primarily based on positive data from the Phase 3 VERIFY study and four-year efficacy and safety data from the Phase 2 REVIVE/THRIVE studies. In the VERIFY study, the clinical response rate of Rusfertide in combination with standard of care more than doubled that of standard of care alone. The therapy achieved significant improvements in hematocrit control, reduction in phlebotomy requirements and alleviation of symptoms such as fatigue in patients, and was generally well-tolerated.
Furthermore, Takeda and Protagonist entered into a global license and collaboration agreement for Rusfertide in January 2024. Protagonist led the development of the therapy through Phase 3 clinical studies, while Takeda is responsible for the U.S. NDA submission and all future global regulatory filings. Protagonist holds an option to co-commercialize Rusfertide in the United States.
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