Takeda And Protagonist Say FDA Grants Priority Review For Rusfertide As Potential First-In-Class Therapy For Polycythemia Vera, Backed By Phase 3 VERIFY Data
Benzinga Newsdesk 8 months ago
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Rusfertide Demonstrated Significant Improvements in Hematocrit Control, Phlebotomy Reduction and Patient Reported Outcomes for Patients with Polycythemia Vera in a Pivotal StudySubmission Primarily Based on Phase 3
- Rusfertide Demonstrated Significant Improvements in Hematocrit Control, Phlebotomy Reduction and Patient Reported Outcomes for Patients with Polycythemia Vera in a Pivotal Study
- Submission Primarily Based on Phase 3 VERIFY Study, in Which Rusfertide Plus Standard of Care More Than Doubled Clinical Response Rates, as Well as Four-Year Efficacy and Safety Data from Phase 2 REVIVE/THRIVE Studies
- Prescription Drug User Fee Act (PDUFA) Target Action Date is in the Third Quarter of this Calendar Year