Shots:
- The US FDA has received an NDA of rusfertide (SC) for the treatment of adults with polycythemia vera (PV)
- NDA was followed by 32wk. primary analysis & 52wk. data from the global P-III (VERIFY) trial (n=293) as well as P-II (REVIVE) study, where VERIFY met its 1EP & all key 2EPs, showing higher response rates, durable hematocrit control, reduced phlebotomy & improved PROs vs PBO
- Under its Jan 2024 global license with Takeda, the NDA filing initiates a 120-day review window followed by a 90-day opt-out period, during which Protagonist may elect to opt out & receive ~$400M, enhanced milestones, & 14–29% tiered global royalties on rusfertide sales
Ref: Businesswire | Image: Takeda & Protagonist | Press Release
Related News: Takeda Reports Topline P-III (LATITUDE) Trials Findings on Zasocitinib in Plaque Psoriasis (PsO)
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