Shots:
- The US FDA has accepted NDA & granted priority review to rusfertide for the treatment of adults with polycythemia vera (PV), with PDUFA action date of Q3’26
- NDA was backed by the 32wk. primary analysis & 52wk. data from the global P-III (VERIFY) trial (n=293) as well as P-II (REVIVE) study & THRIVE LTE study (n=46), where VERIFY met its 1EP & all 4 key 2EPs, showing higher response rates, durable hematocrit control, reduced phlebotomy & improved PROs vs PBO
- In Jan 2024, Protagonist licensed rusfertide to Takeda under a global collaboration: Protagonist led development through P-III, while Takeda oversees US NDA & future filings; Protagonist may co-commercialize in the US via a 50/50 profit & loss-share or grant Takeda full worldwide rights
Ref: Businesswire | Image: Takeda & Protagonist | Press Release
Related News: Takeda Reports Positive P-III (KEPLER) Results of Entyvio in Pediatric Ulcerative Colitis
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