Question · Q4 2025
Erik Lavington asked for more details on why the FDA recommended an additional phase 3 study for Opzelura in prurigo nodularis (PN) and if this has any implications or read-through for Opzelura in hidradenitis suppurativa (HS) or their respective trial designs.
Answer
Steven Stein, CMO, explained that for PN, one phase 3 study was positive while the second narrowly missed its primary endpoint, leading the FDA to recommend a third study. He clarified there is no read-through to the HS program, where two large phase 3 studies are progressing well. Pablo Cagnoni, President and Head of R&D, added that despite missing the primary endpoint, the second PN study showed strong positive results for the Investigator's Global Assessment of treatment success.
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